Total 27 branch manager job vacancies in Quality Assurance / Control category in sgp singapore singapore 70 tuas west dr

Position Overview:

As the Quality Manager, you will be responsible for ensuring the highest quality standards in the development and production of biomedical products. You will lead and manage quality assurance activities across the production process, ensuring compliance with regulatory requirements, industry standards, and company policies. You will play a pivotal role in driving continuous improvement initiatives and fostering a culture of quality within the organization.

Key Responsibilities:

• Oversee and manage the company's Quality Management System (QMS), ensuring compliance with ISO 13485, FDA regulations, and other applicable standards.
• Develop, implement, and maintain quality assurance policies and procedures.
• Lead quality audits, internal and external inspections, and regulatory compliance assessments.
• Monitor and report on quality performance metrics, identifying trends and areas for improvement.
• Manage the resolution of non-conformances, corrective actions, and root cause analysis.
• Collaborate with cross-functional teams (e.g., R&D, Manufacturing, Regulatory Affairs) to ensure product quality throughout the product lifecycle.
• Ensure proper documentation and traceability for all quality-related activities.
• Train and mentor staff on quality processes and regulatory requirements.
• Maintain relationships with regulatory bodies, customers, and suppliers to ensure ongoing compliance and quality standards.

KEY DUTIES AND RESPONSIBILITES:

• Lead and support QC team for daily QC activities by ensuring timely analysis, documentation, and review of RM/PM/FP/IPC/Stability and Process validation samples as per predefined standards.
• Write and / or review controlled documentation related to laboratory operations or testing such as SOP's, analytical protocols, analysis reports, forms and validation documents.
• Ensure compliance with FDA/USP/EP/ICH/ChP regulations and internal controlled procedures in the QC Laboratory.
• Ensure readiness of QC Laboratory in internal / external audits.
• Maintain data integrity in Quality Control activities and ensure appropriate traceability.
• Initiate change control documents.
• Lead and participate in stability program, method validations, technical transfer, method transfer and validation / qualification activities at the site.
• Participate in New Product Introduction activities.
• 9. Lead and participate in laboratory investigations. Document laboratory investigation activities or review and approve laboratory investigation reports.
• Participate in site corrective action / preventive action (CAPA) program. Ensure timely completion of all commitments made under QMS.
• Lead and participate in key performance indicators for improving laboratory efficiency, monitoring equipment performance.
• Lead QC Department training program by imparting training to new staff and comply with Analyst Qualification procedure.
• Escalate the quality events, trends as appropriate to QC Head.
• Remain abreast of current regulatory, pharmacopeia and cGMP trends.
• Serve as subject matter expert on laboratory instrumentation and compliance issues.
• Lead the QC team, evaluate competencies, assign responsibilities, monitor performance, counsel and provide guidance. Plan & monitor the training and development requirements, motivate staff appropriately to build a committed, motivated & competent team.
• Participate in personnel decisions (interviewing, hiring, performance appraisals, promotions, termination, staff development, improvement plans) regarding subordinate staff.
• Maintains a safe laboratory environment by implementing recommendations made by EHS.
• Initiate CAPEX for equipment purchases.
• Support in budget preparation for QC Laboratory.
• Any other activities as and when assigned by the Superior.

JOB REQUIREMENTS:

• EDUCATION: Degree in science or related discipline (e.g. Chemistry, Chemical Engineering).
• EXPERIENCE: Minimum 8 years of quality control experience in pharmaceutical manufacturing industry and minimum 2 years of supervisory experience in managing team.

KNOWLEDGE & SKILLS:

• Possess working knowledge of GMP in the pharmaceutical industry.
• Excellent interpersonal and analytical skills, good verbal, and written communication skills.
• Working knowledge of qualification, calibration, and operation of laboratory equipment such as HPLC, GC, FTIR and Dissolution equipment.
• Working knowledge of method development, validation, verification of analytical method.
• Familiarity of 21 CFR Part 11 requirements.

TO APPLY:

Candidates are encouraged to apply this position via email to [email protected]. with the following information in the resume.

· Work experiences and job responsibilities.

· Current and Expected salary

· Reason for leaving.

· Date of availability

· Education background

We regret that only shortlisted candidates will be contacted.

Task Management

• Develop and implement a comprehensive product quality improvement plan, aligned with the organization'soverall goals and objectives.
• Lead and participate in cross-functional teams to identify and analyse root causes of quality issues.
• Developing and implementing corrective and preventive actions to prevent future quality issues.
• Monitoring and reporting on product quality metrics to track progress and identify areas for improvement.
• Conduct audits and assessments to identify and address potential quality risks.
• Collaborate with suppliers to ensure their products meet our quality requirements.
• Collaborating with various teams such as engineering, manufacturing, classification societies, and suppliers to ensure consistent quality throughout the product lifecycle.
• Stay up-to-date on the latest quality improvement methodologies and tools.
• Track and analyse warranty data for reporting, change implementation to new products and continuous improvement
• Identify and communicate process and product improvements.
• Continually seek to identify areas of quality risk and resolve them before they impact on the vessel.
• Delivery of regular communications & reports to the Key internal relationships.
• Establish and maintain high standards of quality and control of cost within budget limits.
• Carry out customer familiarization of our products.
• Occasional travel to vessels country operating area to conduct fact finding on their operations and acceptance of our products in operation for quality.

Interpersonal Management

• Communicate effectively: This involves actively listening, clearly conveying information, and providing constructive feedback with all levels of staff.
• Build trust and rapport: This involves being genuine, respectful, and reliable.
• Ensure liaison with shipyard personal and management to ensure product quality performance is consistent with the aims of the organization.Develop and maintain key external relationships with partners, customers, contractors, suppliers and official
• bodies and organisations.
• Negotiate on behalf of the company, be able to accept realistic compromises when necessary.
• Develop a strong network of industry suppliers, subcontractors, and contacts.

Information Management

• Develop and manage quality improvement documentation and reporting.
• Develop full understanding of vessel/product specifications and performance.
• Develop full understanding of relevant classification and survey body rules that affect the quality performance of our products.
• Manage warranty claim documentation and continuous improvement feedback documentation to the shipyard.
• Personal Management
• Look for opportunities to continue to develop professionally.
• Show personal accountability for the achievement of objectives.
• Keep up to date with the industry best practice and monitor actions of competitors.

Working Location

31 Joo Koon

Apply via our career portal: https://jobs.thermofisher.com/global/en/job/TFSCGLOBALR01297777EXTERNALENGLOBAL/Manager-QC-Microbiology

Position Summary

In the role of QC Manager (Microbiology) at Thermo Fisher Scientific Inc., you will be responsible for leading all aspects of Quality Control operations. This includes ensuring regulatory compliance, data integrity, and adherence to corporate standards. You will also collaborate with other site functions to provide expertise in biologic microbiology method qualification and validation strategies.

Responsibilities

• Implement and promote the safety message as the top priority for all employees in the organization, and reinforce it across the facility.
• Ensure compliance with Health Authority regulations.
• Collaborate with Sr. Quality Control Manager, Quality Director, and site leadership to improve the Quality Culture.
• Prepare and manage the Quality Control laboratory budget, implementing cost control measures.
• Ensure comprehensive training of personnel in skills, cGMP, and Safety.
• Lead internal audits, regulatory inspections, and customer audits.
• Ensure timely testing, sampling, and release of microbial tests.
• Conduct routine monitoring of classified environments, purified water, process air, and clean utilities.
• Coordinate daily microbiological laboratory activities to align with cGMP and company standards.
• Lead QC groups and support biologics manufacturing, including product testing and system validations.
• Ensure complete and compliant testing to meet production schedules.
• Manage lab documentation, critical reagents, and microbiological cultures.
• Establish and maintain a microbiological laboratory management system.
• Identify and address gaps in compliance with updated regulations.
• Support facility microbial control strategies and coordinate lab investigations and reports.
• Lead laboratory investigations, deviations, and timely closures.
• Support sterility assurance and aseptic process control.
• Report metrics, track schedules, and ensure adherence to timelines.
• Ensure data integrity principles are applied throughout QC processes.
• Hire, develop, and manage professionals within the Quality Control Microbiology group, providing feedback, mentoring, and opportunities for growth.

Minimum Requirements/Qualifications

Education:

• University degree in chemistry, biochemistry, or life sciences, or equivalent experience

Experience:

• 10 years in the pharmaceutical or medical devices industry, Quality Control
• 6 years in a regulated pharmaceutical QC Microbiology laboratory, 4 years of supervisory or management experience

Skills:

• Knowledge of cGMP environment and regulatory expectations
• Technical expertise in QC microbiology and analytical instrumentation
• Strong interpersonal and communication skills in English
• Understanding of applicable regulatory requirements
• Ability to work cross-functionally to meet timelines and objectives
• Experience in Health Agency/internal audits

1. Develop, implement and review company’s compliance and risk management programs and policies.

2. Ensure timely resolution of compliance and risk-related issues.

3. Monitor, evaluate and ensure compliance to rules, regulations, SOPs, and policies.

4. Guide various departments and business units in implementation and/or drafting of SOPs and policies.

5. Conduct relevant research to ensure the company’s compliance with applicable laws and regulations.

6. Advise Management on the implications of new laws and regulations and recommend necessary actions.

7. Provide training and guidance on compliance and risk management best practices.

8. Liaise with Corporate Secretary for corporate governance matters.

9. Assist in all analysis and reporting required by the company and/or parent company.

10. Improve the company’s internal control compliance management and legal risk control system design, establishment and maintenance work.

11. Review and draft contracts as well as providing the relevant advises.

12. Liaise with law firms for legal-related matters.

13. General administration, reporting and filing tasks.

14. Any other duties and responsibilities assigned from time to time.

Requirements:

1. Degree in business admin and related field

2. Minimum 2 years’ experience in company compliance and risk management

3. Meticulous with ability to handle sensitive information and maintain confidentiality

4. Proactive, strives for continuous improvement

5. Multi-task and excellent organization skills, ability to meet deadlines

6. Excellent oral, written and presentation skills

Others Information:

1. 5-day work week

2. Meal subsidized, medical, dental & insurance benefits

3. Company Transport: 2 ways from Jurong East

Job Summary

The QA Manager is responsible for overseeing and managing the quality assurance team, ensuring that all products and services meet organizational standards and customer expectations. The role involves developing and implementing quality assurance processes, leading a team of QA professionals, and collaborating with cross-functional teams to drive continuous improvement in product quality.

Key Tasks:

· Ensure food safety and quality systems (eg. ISO 22000, GMP)

· Execute and monitor procedures related to daily production

· Monitor process flows and ensure its compliance to established parameters

· Evaluate the services of sub-contracted service, for example pest control, cleaning

contractors, etc.

· Plan and monitor shelf life studies for current and new products

· Liaise directly with customers on customer complaints or food safety issues, feedback

· Conduct ISO 22000, GMP and local food authorities’ requirements (AVA/MUIS)

training for relevant staff

· Ensure product consistency

· Work with R&D and production to ensure smooth execution of new products

developed to mass production

· Handle food safety audits by customers, AVA

· Conduct risk assessment profiling for products, ingredients and product contact

materials

Skills & Competencies:

· Diploma/ Degree in Food Science and Technology, Food Nutrition and Dietetics

· Completed ISO, HACCP and/or Risk Management course

· Minimum 6 to 8 years of working experience in food manufacturing environment

· Experience in ISO, HACCP, Risk Management and GMP is an advantage

· Proactive, resourceful and adaptable

· Ability to multi-task and work under pressure

· Good Communications, interpersonal and team interaction skills

· Good diplomacy (to liaise with external parties such as AVA customers, vendors and

other government bodies)

The Healthcare Quality Assurance (QA) Associate Manager communicates the quality policy and objectives to help ensure the maintenance of the overall healthcare compliance for the operation/department. He/She reviews global standard operating procedures (SOPs), reviews and approves client and facility work instructions, trains QA personnel and internal clients on SOPs and regulatory topics, and oversees the maintenance of the quality management system. This position participates in internal, client, and agency audits, and follows up on audit outcomes. He/She maintains knowledge of healthcare quality and regulatory requirements and assesses and addresses risks associated with changes as well as transporting healthcare products. This position oversees multiple facilities and supervises specialists.

Responsibilities

Interfaces with Internal Groups, Clients, and Agencies

• Consults with internal groups (e.g., Operations, Building and System Engineering, Business Development, IT, etc.) and investigates and resolves healthcare issues to ensure compliance with rules and regulations.
• Assists with internal groups (e.g. Business Development, Solutions and Implementation, Operations, IT, etc.) to review new business opportunities to advise on certification and licensing requirements to be in compliance with ever changing local regulations and global SOP.
• Reviews policies, procedures, and regulations with clients to determine specialized requirements and ensure compliance.
• Interfaces with client QA departments and attends sales presentations and business reviews to support the coordination of client activities.
• Participates in regulatory agency interactions to interpret rules and regulations.
• Assists in agency follow-ups after inspections and discovery of internal issues to meet respective agency requirements.
• Follows up with clients after audits to identify issues and mutually acceptable solutions.

Maintains Quality Documents and Procedures

• Writes and revises global standard operating procedures (SOPs) and performs random process adherence audits to ensure adherence to global and client specific processes.
• Establish and maintain postponement activities (e.g. kitting, labelling, bundling, repackaging etc)
• Assists in coordinating document and data control (e.g., numbering, version control, controlled copies, etc.) to ensure documentation and data meet quality standards and are orderly maintained.
• Establishes and maintains quality policies and programs to ensure proper document and data control methods are utilized.
• Assists in interfacing with Corporate Compliance and evaluates procedures across locations to ensure no overlaps and gaps in procedures and guidelines and consistency in content and implementation exist.
• Suggests quality improvements to SOPs, operational/department procedures, and client work instructions to ensure quality standards are maintained.
• Reviews and approves client specific work instructions to ensure consistency and compliance with applicable regulations and UPS quality standards.
• Provides recommendations for changes to work instructions as necessary to accurately reflect regulations and UPS quality standards.

Supervises And Develops Others

• Determines employees’ training needs to produce continuous development plans.
• Provides on-going feedback and support to improve performance.
• Conducts performance evaluations in a consistent, fair, and objective manner to encourage continuous performance improvement.
• Holds others accountable to established performance levels to achieve individual and group goals.
• Resolves individual and group performance issues in accordance with UPS’s policies and procedures in a timely manner to motivate and foster teamwork.

Manages and Executes Quality System Training Program

• Identifies any necessary and applicable Quality System requirements to ensure appropriate training content.
• Performs necessary Good Manufacturing Practices (GMP)/Good Distribution Practices (GDP) and SOP training to ensure appropriate level of compliance is maintained in the operations/department.
• Identifies and approves all qualified trainers to ensure training quality.
• Assists in the development and maintenance of all necessary training material to ensure quality and accuracy of content.
• Oversees the tracking and reporting of required employee training for the facility/department to ensure compliance.

Conducts and Oversees Internal and External Audit Programs

• Participates in information gathering and scheduling and prepares and distributes reports to prepare for internal and client audits.
• Performs internal audits, interacts with internal auditees, and records information and observations to track and trend audit findings, take corrective and preventative action, and maintain proof of audits and documentation.
• Hosts and responds to Corporate Compliance and agency audits to identify and conduct follow-up activities.

Requirements:

• Possess a Degree in Science or Life Sciences related
• Need to be a license Pharmacist and willing to be a license holder for SG Healthcare facilities
• Brings along at least 5 years of work experience in pharmaceutical/medical device logistics related field
• Good interpersonal skills with the attributes of a team player and a keen eye for details
• Ability to collaborate and work effectively with a variety of stakeholders
• Able to travel occasionally to APAC countries
• This position is based in the West (1 Gul Circle).

Qualification: Degree in Engineering preferably Chemical or Mechanical or Diploma with min 5 years Quality experience.

Job Requirements: Minimum 5 years working experience in manufacturing environment preferably in Quality. Knowledge of ISO 9000, ISO 14001 and ISO/TS 16949 Computer Literate. Able to work independently and a team player.

Reporting Level: Quality Engineering Manager/ Artwork and OF Manager

Duties and Responsibilities:

1.1. To support the Quality Manager to meet the company objectives and goals.

1.2. Manage activities of incoming inspection to assure that materials used meet quality requirements

1.3. Oversee the product inspection activities within the company and QA activities within the department.

1.4. Overseeing outgoing inspections to ensure products meet customer requirements, including 100% firewall activities.

1.5. Developing, reviewing, and approving quality control methods and procedures to ensure that products meet customer specifications

1.6. Conduct training sessions for staff on quality standards, procedures, and best practices.

1.7. Manage and maintain quality documentation; and Prepare and review quality reports, metrics, and key performance indicators (KPIs)

1.8. Handling and managing customer complaints, coordinating with relevant departments for resolution, and ensuring timely responses to customers.

1.9. Prepare and manage corrective and preventive action reports (e.g., 8D reports) or relevant report(s) to customer.

1.10 Develop and initiate quality improvement programs, coordinating with internal departments and external parties (e.g., suppliers) to ensure successful implementation and measurable improvements.

1.11 Implement and uphold quality, environmental, and safety management systems such as ISO 9001,IATF 16949, ISO 14001, and applicable safety regulations. Represent management as Quality Management Representative (QMR) or Environmental Management Representative (EMR) in

these systems' implementation and maintenance.

1.12 Promote quality, environmental awareness.

1.13 Manage the activities of the Document Control Center.

1.14 Ensure that all measuring and test equipment are calibrated and in good condition as required.

1.15 Manage the handling of non-conforming products by stopping processes if necessary and ensuring that deficiencies are addressed and corrected before resuming production.

1.16. Assist the Quality Manager in strategic planning and decision-making and Provide input for setting quality objectives and goals.

1.17 Undertake additional tasks or responsibilities as directed by a superior.

· Prepare, review and negotiate various legal documents, correspondences with external parties, SOPs and policies.

· Assist to guide the various departments and business units to implement and/or draft SOPs and policies.

· Handle litigation/legal cases by liaising with internal stakeholders and external lawyers engaged by the company.

· Assist to provide legal advice and support to various departments and business units on matters related to contracts, regulatory compliance and risk management.

· Conduct legal research to ensure the company’s compliance with applicable laws and regulations.

· Draft advice to management on the implications of new laws and regulations and recommend necessary actions.

· Assist in evaluation of compliance to rules, regulations, SOPs and policies.

· Maintain and update database of existing and new agreements, SOP and policies.

· Assist in all analysis and reporting required by the company and/or the parent company.

· Assist with the improvement of the company’s internal control compliance management and legal risk control system design, establishment and maintenance work.

· General administration, reporting and filing tasks.

· Adhere to all company rules and regulations including safety rules.

· Any other duties and responsibilities assigned from time to time.

Requirements:

1. Preferably Law graduate with 2 years of experiences in law firm or in-house legal advisor (preferably in MNCs/logistics/commercial industry)

2. Proficient in legal research and legal document drafting and reviewing

3. Meticulous with ability to handle sensitive information and maintain confidentiality

4. Proactive, strives for continuous improvement

5. Ability to work independently, with integrity and responsibility

6. Multi-task and excellent organization skills, ability to meet deadlines

7. Excellent oral, written and presentation skills

Others Information:

· 5-day work week

· Meal subsidized, medical, dental & insurance benefits

· Company Transport: 2 ways from Jurong East

Main Responsibilities:

• Enforce food safety & quality systems (e.g. ISO 22000, GMP)
• Liaise directly with customers on quality / food safety issues, feedback
• Establish & ensure accuracy of information / documents (eg. product specifications) provided to customer
• Establish and improve food safety systems & standard of procedure ( SOP )
• Conduct food safety audits and ensure product consistency
• Work with R&D and Production to ensure smooth execution of new products developed to mass production
• Handle food safety and Halal audits by customers, AVA, MUIS etc Microbial testing knowledge required
• Work with Group QA/QC head to set corporate wide target and focus area
• Develop corporate wide retail product quality monitoring system (e.g. consumer complaint system; market quality monitoring system)
• Support marketing team in customer/consumer quality complaint handling

Job Requirements:

· Degree in Food Technology, Food Science, Chemistry or Microbiology.

· 7 years’ experience in Quality Assurance or Quality Management, preferably in Food Industry.

· Experience in cross countries / regional role with interaction to Senior Supply Chain or Business Management.

· Experience in managing food safety and/or quality issues including direct communication to consumer/customer.

· Knowledge and understanding of applicable legislation and standards across multiple international jurisdictions.

· Good interpersonal and communication skills.

Our Quality group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

WHAT YOU WILL DO

Reporting to Senior Manager, Quality Control, you will be responsible for, but are not limited to:

1) Provide change control oversight for Supplier, Manufacturing, Engineering, Warehouse, Incoming Laboratories and Finished Product Laboratories in Pharm or API plants.

2) Provide Quality Operation related impact assessments for change controls. 3) Review and approve supplier, manufacturing, warehouse, facilities, utilities and analytical change controls.

4) Plan, material control for the incoming material and final product release which are impacted by change controls.

5) Review and approve validation protocols, reports and other validation related documents for manufacturing equipment’s, HVAC & utility systems, lab chambers.

6) Review and approve validation documents in compliance with validation requirements.

7) Partner with other site QA and change owner / project lead to complete the change control/project on time.

8) Support site management in continuous improvement efforts in streamlining change control practices for efficiency, consistency and compliance, e.g. Accelerate or Hoshin.

9) As a subject matter expert, be able to respond to enquiries related to QA and projects and approaches during internal and external audits and inspections, and work on audit responses and follow-up actions as needed.

10) Any other duties assigned by the manager.

WHAT YOU SHOULD HAVE

To be successful in this role, you should have good knowledge on cGMP, GDP and Quality Assurance and change control. Be passionate about teamwork and knowledge sharing, and proactive on continuous improvement. Other pre-requisites and attributes include:

1) Possess a Bachelor’s degree in Chemistry/Chemical Engineering or related Sciences, with a minimum of 3 years of experience in QA position in pharmaceutical or related industry.

2) Good knowledge and understanding of GMP and data integrity requirements. Good coaching, communication and interpersonal skills.

3) Demonstrate the ability to actively seek opportunities to continuously improve and simplify processes and procedures.

Other Personal Attributes:

• Self-motivated
• Independent
• Team Player
• Highly Approachable

WHAT YOU CAN EXPECT

• Limitless opportunities across various areas in Manufacturing; well-structured career path
• A state-of-the-art facility that delivers solution to its customers world-wide

Job Descriptions :

• Leadership and Coordination: Spearhead the delivery of Quality work scopes ensuring seamless coordination among stakeholders and compliance with applicable requirements. You’ll work alongside functions such as Package Mgmt, H&S, Engineering, Construction, Supply & Expediting, Commissioning, Project Controls, Contract Management, Legal, and Procurement.
• Quality Management: Drive project to completion on time, within budget, and to the highest quality and HSE standards. Develop and maintain project Quality schedules, budgets, and forecasts, contributing directly to Company’s Renewable strategy. Ensure compliance to Project Quality requirements are met.
• Design and execute a comprehensive strategy that integrates quality management with sustainability goals to support growth objectives
• Supervise, coach and engage the Quality team to strive for excellence, to deliver solutions that meet high-level quality standards
• Continuously improve customer satisfaction by handling customer complaints promptly and professionally
• Ensure products meet quality standards before reaching customers.
• Oversee all new product development procedures, ensuring that sustainability considerations and internal controls are integrated from the beginning.
• Risk Management: Effectively manage project risks, specifically those intrinsic to the offshore wind industry, manufacturing, Quality Assurance/Quality Control, and supply chain challenges.
• Ensure that the lessons learned are effectively captured and communicated during the project
• Expected to travel to Batam to monitor and control the construction progress and customer meetings.

Job Requirements :

• Bachelor’s degree or higher in Engineering, Mechanical Engineering, or a related field.
• 5-8 years of experience managing quality of Shipyard and installation. Experience in Quality Assurance and Quality Control for onshore / offshore wind projects, preferably specific to Offshore substation construction
• Proven success in quality and process management, with a track record in quality control and continuous improvement.
• In-depth knowledge of Quality Management Practices and standards such as ISO, APQP, PPAP, FMEA, MSA, REACH, ROHS.

KEY DUTIES AND RESPONSIBILITES:

1. Lead and support QC team for daily QC activities by ensuring timely analysis, documentation, and review of RM/PM/FP/IPC/Stability and Process validation samples as per predefined standards.

1. Write and / or review controlled documentation related to laboratory operations or testing such as SOP's, analytical protocols, analysis reports, forms and validation documents.
2. Ensure compliance with FDA/USP/EP/ICH/ChP regulations and internal controlled procedures in the QC Laboratory.
3. Ensure readiness of QC Laboratory in internal / external audits.
4. Maintain data integrity in Quality Control activities and ensure appropriate traceability.

6. Initiate change control documents.

1. Lead and participate in stability program, method validations, technical transfer, method transfer and validation / qualification activities at the site.
2. Participate in New Product Introduction activities.

9. Lead and participate in laboratory investigations. Document laboratory investigation activities or review and approve laboratory investigation reports.

1. Participate in site corrective action / preventive action (CAPA) program. Ensure timely completion of all commitments made under QMS.
2. Lead and participate in key performance indicators for improving laboratory efficiency, monitoring equipment performance.
3. Lead QC Department training program by imparting training to new staff and comply with Analyst Qualification procedure.
4. Escalate the quality events, trends as appropriate to QC Head.
5. Remain abreast of current regulatory, pharmacopeia and cGMP trends.
6. Serve as subject matter expert on laboratory instrumentation and compliance issues.
7. Lead the QC team, evaluate competencies, assign responsibilities, monitor performance, counsel and provide guidance. Plan & monitor the training and development requirements, motivate staff appropriately to build a committed, motivated & competent team.
8. Participate in personnel decisions (interviewing, hiring, performance appraisals, promotions, termination, staff development, improvement plans) regarding subordinate staff.
9. Maintains a safe laboratory environment by implementing recommendations made by EHS.
10. Initiate CAPEX for equipment purchases.

20. Support in budget preparation for QC Laboratory.

21. Any other activities as and when assigned by the Superior.

JOB REQUIREMENTS:

· EDUCATION: Degree in science or related discipline (e.g. Chemistry, Chemical Engineering).

· EXPERIENCE: Minimum 8 years of quality control experience in pharmaceutical manufacturing industry and minimum 2 years of supervisory experience in managing team.

KNOWLEDGE & SKILLS:

• Possess working knowledge of GMP in the pharmaceutical industry.
• Excellent interpersonal and analytical skills, good verbal, and written communication skills.
• Working knowledge of qualification, calibration, and operation of laboratory equipment such as HPLC, GC, FTIR and Dissolution equipment.
• Working knowledge of method development, validation, verification of analytical method.
• Familiarity of 21 CFR Part 11 requirements.

Task Management

• Develop and implement a comprehensive product quality improvement plan, aligned with the organization'soverall goals and objectives.
• Lead and participate in cross-functional teams to identify and analyse root causes of quality issues.
• Developing and implementing corrective and preventive actions to prevent future quality issues.
• Monitoring and reporting on product quality metrics to track progress and identify areas for improvement.
• Conduct audits and assessments to identify and address potential quality risks.
• Collaborate with suppliers to ensure their products meet our quality requirements.
• Collaborating with various teams such as engineering, manufacturing, classification societies, and suppliers to ensure consistent quality throughout the product lifecycle.
• Stay up-to-date on the latest quality improvement methodologies and tools.
• Track and analyse warranty data for reporting, change implementation to new products and continuous improvement
• Identify and communicate process and product improvements.
• Continually seek to identify areas of quality risk and resolve them before they impact on the vessel.
• Delivery of regular communications & reports to the Key internal relationships.
• Establish and maintain high standards of quality and control of cost within budget limits.
• Carry out customer familiarization of our products.
• Occasional travel to vessels country operating area to conduct fact finding on their operations and acceptance of our products in operation for quality.

Interpersonal Management

• Communicate effectively: This involves actively listening, clearly conveying information, and providing constructive feedback with all levels of staff.
• Build trust and rapport: This involves being genuine, respectful, and reliable.
• Ensure liaison with shipyard personal and management to ensure product quality performance is consistent with the aims of the organization.Develop and maintain key external relationships with partners, customers, contractors, suppliers and official
• bodies and organisations.
• Negotiate on behalf of the company, be able to accept realistic compromises when necessary.
• Develop a strong network of industry suppliers, subcontractors, and contacts.

Information Management

• Develop and manage quality improvement documentation and reporting.
• Develop full understanding of vessel/product specifications and performance.
• Develop full understanding of relevant classification and survey body rules that affect the quality performance of our products.
• Manage warranty claim documentation and continuous improvement feedback documentation to the shipyard.
• Personal Management
• Look for opportunities to continue to develop professionally.
• Show personal accountability for the achievement of objectives.
• Keep up to date with the industry best practice and monitor actions of competitors.

Authorities and Responsibilities

1. Responsible for providing directives for the Quality Assurance Department in meeting management objectives.
2. Formulate, implement and evaluate quality strategies programs for the company.
3. Implement and maintain a system of auditing the facility and periodic calibration of test, measuring equipment and tools.
4. Manage customer complaints, corrective and preventive action programs.
5. Administer and manage continuous improvement program for all QA processes.
6. Work closely with auditors, customers, production and suppliers to meet the quality requirements.
7. Manage sub-contractors for on-time supply of treatment process, as well as meeting technical requirement.
8. Review / prepare, administer and implement Quality Assurance Plans, Inspection Test Plans and other Operational procedures in accordance to the technical specifications, customer's surveillance requirements, and good manufacturing / engineering practices, and enforce the same on Operations in their execution.
9. Work closely among inter-department to ensure committed schedules are met in a timely and effectively manner.
10. Review and approve disposition program / action for nonconforming products.
11. Ensure that processes needed for the quality management system are established and implemented.
12. Report to top management on the performance of the quality management system, and note needed improvements.
13. Ensure the promotion of awareness of statutory, regulatory and customer requirements throughout the organization.
14. Ensure and coordinate the implementation of risk assessment and risk control of medical devices

The Quality Assurance Manager plays a crucial role in business by ensuring that products meet certain standards of quality. He/She plans, directs or coordinates quality assurance programs and formulate quality control policies. He/She also works to improve an organisation's efficiency and profitability by reducing waste. He/She prepares and update quality documentation, basing their processes on a recognised standard such as ISO 9000 – Quality Management, published by the International Organisation for Standardisation. He/She supervises teams of inspectors who carry out the detailed assessment of products and their components at different stages of production. He/She recruits and trains supervisors, and provides them with documented quality standards as guidelines for their daily work. He/She also selects quality inspection tools and software to support the inspection team.

Competence Requirements:

• Diploma in Mechanical Engineering / Quality Engineering or equivalent.
• Minimum 6 years of solid experience in Quality Management in similar or related industry and 3 years in management level.
• Good knowledge in implementing and up keeping Quality Management System.
• Strong leadership and good interpersonal skills.
• A team player with strong sense of responsibility to ensure plant effective quality performance.

~ Assist in the implementation of company quality systems.
~ Conduct Quality Assurance audit.
~ Manage cause investigation for non-conformance.
~ Manage company quality systems.
~ Manage departmental activities and deployment.
~ Able to commute between Tuas Plant and Loyang Plant.

• To promote a Zero Harm culture & best practices through the implementation of a tailored safety, quality and environmental management system including the development and implementation of appropriate policies & procedures to ensure a safe and efficient workplace.
• To ensure regulatory compliance & due diligence to safety, health, quality, dangerous good/hazardous substances and environmental obligations.
• To liaise with all business units on matters relating to safety, quality and environment including potential non-compliance of a regulatory nature.
• Compliance with all relevant safety, quality, environmental & P&C policies & procedures to ensure a safe work environment at all times.
• Actively liaise with all departments to ensure quality control, quality assurance and safe practices are adhered to at all times.
• Work with A-Gas management to implement its policies, procedures, work instructions, mission and goals.
• Lead by example in demonstrating personal qualities, behavioural traits and A-Gas values & behaviours.
• Timely management reporting in the manner and form as required from time to time.
• Perform site inspections as required.
• Actively participate in internal & external project meetings and provide sound recommendations on SQE initiatives and/or highlight any deviations & possible risks if any.
• Manage & maintain integrated certified Safety, Quality, Environmental management systems to ensure continued compliance to ISO 9001, ISO45001, ISO14001, ISO17025 (NATA), and other relevant standards like ISO 31000 where applicable.
• Identify and maintain compliance to relevant WHS, Environmental & other acts, regulations, codes of practices & guidelines etc.
• Audit SQE Management System, including reviewing, monitoring, measuring, reporting on performance.
• Recommend and implement continual improvement to the SQE system, work instructions and associated processes.
• Promoting awareness of SQE requirements, communicating and consulting with all staff & other stakeholders on SQE processes, documentation and regulatory requirements.
• Development and implementation of SQE documentation relevant but not limited to procedures, plans, hazard and aspect identification, risk assessments, emergency preparedness & response, design & development, management of change, control measures, management review including ad hoc measures based on current environmental occurrences.
• Actively lead & participate in Operational Safety, Process Safety, Risk Assessment, HAZOPs, Pre-Purchase Risk Assessments, Management of Change & Design & Development, SQE incident investigation & root cause analysis and processes.
• Active participation and collaborating to provide SQE / technical advise as required to the Lab Team, Customer Service, Operations, Engineering, Rapid Recovery and wider A-Gas Group & other relevant stakeholders.

Get to Know the Team:

We are looking for a Compliance Officer to join our Grab Direct General Insurer team based in Singapore. Our team focuses on ensuring that we uphold the highest standards of compliance, aligning with regulatory requirements and fostering a culture of integrity within our organization.

Get to Know the Role:

As a Compliance Officer, you will play a central role in maintaining our compliance framework. You'll be responsible for developing and implementing policies that adhere to regulations and industry standards while staying updated on any changes that may affect our business.

You will report to the Associate General Counsel, GrabFin.

This role will be onsite at Grab Office.

The Critical Tasks You will Perform:

• You will develop, implement, and maintain compliance policies and procedures that align with regulatory requirements and best industry practices.
• You will monitor and assess the company's adherence to relevant laws and regulations including the Insurance Act, Anti-Money Laundering (AML) regulations, and data protection laws.
• You will conduct regular compliance audits and risk assessments to identify potential compliance issues and recommend corrective measures.
• You will provide training and guidance to employees on compliance matters to ensure awareness and understanding of responsibilities.
• You will liaise with regulatory authorities and respond promptly to inquiries, ensuring timely submission of reports and required documentation.
• You will investigate compliance breaches and recommend appropriate disciplinary actions or remedial measures.
• You will stay updated on regulatory changes and industry trends, advising management on potential impacts.
• You will collaborate with departments such as risk management and internal audit to maintain a cohesive approach to compliance.
• You will prepare and present compliance reports to senior management and the board of directors.

Team Summary

Visa is looking for a Compliance Manager based in Singapore to be part of Currencycloud’s Asia Pacific (APAC) Compliance and Regulatory team. Currencycloud is part of Visa Group entities and covers Visa’s regulated payment business within Money Movement Solutions (MMS) in APAC. Currencycloud is also consolidated under Visa Direct which streamlines all of Visa’s cross border payments under one unified branding. The Currencycloud APAC Compliance and Regulatory team serves as a critical partner to the MMS business, providing pragmatic, solutions-oriented advice to ensure that the regulated payment activities within licensed entities in APAC are in line with the local regulatory requirements where the licensed entities are operating in as well as Visa’s group standards. The team is part of the second-line Compliance function within Visa’s Group Compliance.

What a Compliance Manager does at Visa:

Based in Singapore, this position will support the Currencycloud APAC Head of Compliance and Regulatory who is also the Money Laundering Reporting Officer (MLRO) of Visa’s regulated entity as a Major Payments Institution (MPI) in Singapore, covering AML/CFT and Sanctions compliance matters. This position will be reporting to the Currencycloud APAC Head of Compliance and Regulatory based in Singapore and is a newly created position as part of Visa’s expansion plans within the APAC region.

The core responsibilities for this role are as follows:

·       Support Singapore MLRO in the development and maintenance of robust AML/CFT and Sanctions frameworks which are in line with the Singapore’s Payment Services Act (PSA) and the relevant subsidiary legislations issued by the Monetary Authority of Singapore (MAS) as well as Visa’s Global Compliance and other International AML/CFT and Sanctions standards. This includes preparation of responses in relation to any request for information from regulatory authorities on a timely basis and/or during regulatory inspections.

·       Perform ongoing assessment of AML/CFT and Sanctions controls, including participate in Enterprise-Wide Risk Assessment (EWRA) exercise, review of Transactions Screening and Monitoring logics to ensure that sufficient and robust controls are in place to meet the regulatory requirements as well as in line with market / industry standards.

·       Responsible for identification and reporting of suspicious transactions (STR), including maintenance of proper records on all investigations and reviews based on trigger events, transaction alerts or escalation channels, provision of additional information where required by Commercial Affairs Department (CAD) and other law enforcement agencies.

·       Support the APAC Client Migration Project upon activation of Singapore license, including preparation of KYC uplift requirements and review of incremental KYC documentations upon submission by relevant clients.

·       Perform horizon scanning of AML/CFT and Sanctions legislations, including gap and impact analysis on consultation papers, new circulars, notices etc.

·       Handle AML/CFT, Sanctions and other related regulatory audits and ensure that the reviews commensurate with the nature, size and complexity of the regulated activities within the business and the ML/TF risks arising from those businesses; track progress of remedial plans arising from audit and/or regulatory inspection findings.

·       Work closely with first-line Compliance function such as the New Business Onboarding (NBO) team who is responsible for Customer Due Diligence (CDD) and Enhanced Due Diligence (EDD) at point of client onboarding. Provide relevant and timely guidance and where required, participate in the client review process on a case-by-case basis.

·       Provide guidance to the Periodic Review team over clients’ refreshers and provide specific case review support where required,

·       Perform AML/CFT related review on banking and network partners, third party service providers etc.

·       Address communications and request for information from clients, banking and network partners in relation to AML/CFT matters.

·       Develop AML/CFT and other related training materials and conduct training to the business stakeholders on a regular basis. Maintain all training records and attendance where required.

·       Provide accurate and timely advice to the Business over AML/CFT and other related regulatory requirements, ensuring that risks are being adequately managed while balancing business objectives.

·       Responsible for comprehensive reporting including local dashboard and metrics reporting

·       Participate actively in Regional and Global team discussions, including sharing of local practices, updating on regulatory developments etc.

This is a hybrid position. Hybrid employees can alternate time between both remote and office. Employees in hybrid roles are expected to work from the office 2-3 set days a week (determined by leadership/site), with a general guidepost of being in the office 50% or more of the time based on business needs.

Quality Assurance Manager closely organize and manage the Quality Assurance Department by collecting and reporting accurate study data to ensure that quality of products comply with local authority regulations, protocol requirements and Company's objectives and practices.

1. To evaluate the staff performance on their quality and efficiency based on the work assignment given.

2. To review job contribution of the staff and appraise based on the expectation communicated and quality of work done.

3. To develop and recommend the KPI used to appraise staff and get management approval before implementing.

4. To update the departmental scope from time to time by studying trends in and developments in quality management and translate into a KPI.

5. To ensure ongoing compliance with the PIC/S Guideline for GMP.

6. To achieve quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; identifying and resolving problems; completing audits; determining system improvement; implementing change.

7. To effectively develops, coaches and manages a team a team of quality professionals of Singapore and Malaysia to implement cGMP requirements as per PICs or other recognised reference and continuous improvement in quality operations.

8. Develops and implements a practical system for Quality Management System activities to facilitate smooth, timely workflows in the performance of job function.

9. To provide leadership, guidance, interpretation, information on regulations, laws and industry guidance that affect pharmaceutical industry.

10. Serve as a SME in matters relating to quality assurance and cGMP.

11. Ensure facility follows applicable quality management directives such as SOPs, manuals, policies, procedures, work instruction, etc.

12. Responsible for reviewing, trending and investigating excursions of environmental monitoring and supportive utilities data.

13. The inspection and investigation of product recalls and product complaints to look into factors which has affect product quality.

14. Acts as the Authorised Person to perform batch release and ensure each batch of medicinal products are manufactured and checked in compliance with the laws in force in the country and in accordance with the requirements of the Marketing Authorisation.

15. Reviews, approves or authorises written procedures and other documents, including amendments.

16. Oversees various quality management systems and analyse trending.

17. Reviews and approves deviations and CAPA.

18. Review, approves and implement changes according to established Change Control procedure.

19. Coordinates and participates in quality risk management activities.

20. Initiates investigation for product complaints, reviews and approves corrective/preventive actions associated.

21. Coordinates product recalls, associated reconciliation, documentation and investigations.

22. Reviews, approves and monitors suppliers of materials.

23. Reviews, approves and monitors contract manufacturers and providers of other GMP related outsourced activities.

24. Ensures validation and qualification are carried out according to schedule.

25. Provides training or ensures appropriate training is provided to QA staffs.

26. Monitors compliance of the organisation with the requirements of Good Manufacturing Practice via Internal Audit.

27. Coordinates management reviews of process performance, product quality and Pharmaceutical Quality System and advocates continual improvement

28. Ensures timely and effective communication and escalation process exists to raise quality issues to appropriate levels of management.

We are seeking a passionate Senior Quality Assurance Executive/ Assistant Quality Assurance Manager for our brands—Neo Garden Catering / Deli Hub Catering — as part of our department expansion! You will be responsible for ensuring all hygiene and food safety standards at the assigned locations.

• Lead and conduct daily on-site inspections, ensuring compliance with quality standards, food safety regulations, and operational procedures across production and retail outlets.
• Supervise and conduct personal hygiene checks, product quality assessments, and sample retention protocols to ensure adherence to internal and external standards.
• Develop, implement, and oversee the laboratory testing and sampling schedules, ensuring all critical tests are conducted in accordance with product specifications and regulatory requirements.
• Analyze test results and recommend corrective actions for any deviations or non-conformities.
• Implementation and continuous improvement of the ISO 22000:2018 Food Safety Management System (FSMS) for relevant operations.
• Oversee and updates of the Quality Management System and Standard of Procedure, ensuring alignment with industry best practices and regulatory changes.
• Work closely with relevant departments to ensure operational adherence to standards, and address any discrepancies or audit findings.
• Ensure the accuracy, completeness, and proper retention of all quality assurance records, documents, and files as per regulatory and company policies.
• Perform regular audits of quality documentation and lead the improvement of record-keeping practices.
• Serve as the primary point of contact for external auditors and internal audits.
• Coordinate with departments to ensure compliance with quality standards during audits and external inspections.
• Develop, review, and enhance Standard Operating Procedures (SOPs) across all areas of operations to ensure best practices in quality assurance and food safety.
• Development and continuous improvement of food safety training materials, ensuring they are relevant, up-to-date, and aligned with company policies and industry standards.
• Identify and mitigate quality risks, ensuring proactive measures are taken to prevent non-conformities and quality failures.
• Communicate quality-related issues and improvements to stakeholders, ensuring alignment across all levels of the organization.

Requirements

• A level, Diploma or equivalent, in Food Science/ Technology/ any related standard
• Possess knowledge in SFA regulation, ISO 22000, Halal/ any other related standard
• Able to multitask and work within timeline
• Good communication skills
• Team player, proactive and meticulous in work
• Open to working in the West and on weekends

The level of appointment offered will commensurate with candidate's experience.

Interested applicants are invited to apply with your detailed resume via the “Apply Now” option.

We thank you for your interest and regret that only shortlisted candidates will be notified.

• Supervise and oversee junior team members and review their work product
• Review and draft compliance documents, frameworks and templates, covering all aspects of regulatory compliance
• Analysing and summarising MAS publications and regulatory updates
• Develop training programs, with opportunities to provide training to clients
• Other ad-hoc duties as required

•Working with Process Engineer & Engineering team on QC requirement.

•Documenting inspection criteria and quality plan.

•Work with QA, Process and Product team on corrective action with quality issue.

•Work with Process team on in-process audit and FQC audit.

•Control of Supplier Quality Assurance (SQA).

•Quality control of in-coming, in-process and out-going products.

•Assist in Project team/Construction team.

•Quality check on finishing work accordance to method of statement

•Prepare and compile report after inspection.

•Plan on construction site visit and liaise with Project Manager or Engineer

•Liaise with Authority for Certification

•Provide Training to workers accordance to method of statement.

1. Lead and support QC team for daily QC activities by ensuring timely analysis, documentation, and review of RM/PM/FP/IPC/Stability and Process validation samples as per predefined standards.
2. Write and / or review controlled documentation related to laboratory operations or testing such as SOP's, analytical protocols, analysis reports, forms and validation documents.
3. Ensure compliance with FDA/USP/EP/ICH/ChP regulations and internal controlled procedures in the QC Laboratory.
4. Ensure readiness of QC Laboratory in internal / external audits.
5. Maintain data integrity in Quality Control activities and ensure appropriate traceability.
6. Initiate change control documents.
7. Lead and participate in stability program, method validations, technical transfer, method transfer and validation / qualification activities at the site.
8. Participate in New Product Introduction activities.
9. Lead and participate in laboratory investigations. Document laboratory investigation activities or review and approve laboratory investigation reports.
10. Participate in site corrective action / preventive action (CAPA) program. Ensure timely completion of all commitments made under QMS.
11. Lead and participate in key performance indicators for improving laboratory efficiency, monitoring equipment performance.
12. Lead QC Department training program by imparting training to new staff and comply with Analyst Qualification procedure.
13. Escalate the quality events, trends as appropriate to QC Head.
14. Remain abreast of current regulatory, pharmacopeia and cGMP trends.
15. Serve as subject matter expert on laboratory instrumentation and compliance issues.
16. Lead the QC team, evaluate competencies, assign responsibilities, monitor performance, counsel and provide guidance. Plan & monitor the training and development requirements, motivate staff appropriately to build a committed, motivated & competent team.
17. Participate in personnel decisions (interviewing, hiring, performance appraisals, promotions, termination, staff development, improvement plans) regarding subordinate staff.
18. Maintains a safe laboratory environment by implementing recommendations made by EHS.
19. Initiate CAPEX for equipment purchases.
20. Support in budget preparation for QC Laboratory.
21. Any other activities as and when assigned by the Superior.

EDUCATION:

Degree in science or related discipline (e.g. Chemistry, Chemical Engineering).

EXPERIENCE:

Minimum 8 years of quality control experience in pharmaceutical manufacturing industry and minimum 2 years of supervisory experience in managing team.

KNOWLEDGE & SKILLS:

1. Possess working knowledge of GMP in the pharmaceutical industry.
2. Excellent interpersonal and analytical skills, good verbal, and written communication skills.
3. Working knowledge of qualification, calibration and operation of laboratory equipment such as HPLC, GC, FTIR and Dissolution equipment.
4. Working knowledge of method development, validation, verification of analytical method.
5. Familiarity of 21 CFR Part 11 requirements.

Quality Management System:

• Responsible for quality oversight of operations at PharmaGend Global Medical Services Pte Ltd facility. Adhere to laid down Quality Management System, its effective implementation and facilitate continuous improvement in all manufacturing area activities, and effective resolution of routine Quality issues.
• Tracking, trending and closing QMS events using TrackWise. Review and Approval of documentation associated with key quality compliance indicators - Deviation, Market Complaints, Product Recalls, CAPAs, Change Controls, Returned Goods and other quality system documents e.g., Product Quality Review, SOP's, Protocols, reports as appropriate; and actively participate in investigations.
• Subject matter expert in Qualification and Validation activities related to GMP area, production equipment and key utilities e.g., Purified water system, Compressed air system.
• Review periodically the Quality Performance parameters, review and approve appropriate remedial actions towards compliance and Quality of products supplied. Identify proactively the actions towards continuous improvement and measure performance of Quality through various tools / Quality Indicators.
• Escalate the quality events, trends as appropriate to various management levels in organization for appropriate regulatory actions as applicable and provide close-out actions as deemed necessary / required.
• Ensure timely review and / approval of executed batch records, and final batch release to market. and disposition (Release/Rejection) of in-process and finished product batches as appropriate.
• Implement ongoing process management mechanisms (process mapping, documentation, metrics, monitoring systems and process control techniques).
• Perform periodic review of Quality Performance parameters and approve appropriate remedial actions towards compliance and Quality of products supplied. Identify proactively the actions towards continuous improvement and measure performance of Quality through various tools / Quality Indicators, provide Quality Management Reports.
• Escalate the quality events, trends as appropriate to various management levels in organization for appropriate regulatory actions as applicable and provide close-out actions as deemed necessary / required.
• Conduct internal audits and/or vendor audits as required.
• Ensure the SOPs are in line with the practice and revision thereof if required.
• To ensure that the facility is kept all time ready to handle any regulatory, customer or internal audit.
• Act as a designee to for Head Quality on QMS related matters.

Documentation Compliance:

• Review and approval of master BMR/BPR and issuance of BMR/BPR.
• Control and Management of archived documents.
• Preparation and Review of SOPs/Work instructions and forms related to quality assurance and cross functional departments.
• Review and approval of protocol and reports.
• Ensure effective control of confidential and all technical documents and information networking, timely review and approval of relevant technical documents.

Quality Risk Management:

• Participate in Identification and implement risk approach in validation / qualification area based on overall risk management policy / guidelines to control / mitigate risks.
• Apply risk management tools and techniques.

People Management including Technical Training:

• Assign responsibilities, monitor performance, counsel & provide feedback on team performance, plan & monitor required training and development to ensure a committed & competent team.
• Build strong and positive cross-functional working relationships by working to include them in the improvement activities/training, making sure their needs and requirements are carefully considered.
• Conduct Technical Training (On the Job as well as Classroom) to fellow colleagues, new employees and cross functional team.

Management of interface with Regulators/Customers

• Interact with customers/regulatory bodies in a timely manner to address quality / technical related events to ensure desired outcome and adherence to regulatory commitment and compliance.
• Interpret current Regulatory guidance and implement at site.
• Management technical agreement with ESP and clients.
• Updating GMP Documents as per Regulatory amendments and process requirements.
• Ensure compliance with various regulatory commitments, regulatory requirements and customer requirements as applicable including policies.

Requirements:

• Bachelor’s degree and/or Maste’s degree in Pharmacy or Chemistry.
• At least 10 to15 years of experience, demonstrated ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality and outside of the function.
• More than 8 years’ experience in pharmaceutical validation, qualification projects.
• In-depth understanding of Manufacturing/Pharma Business
• Strong team leadership skills
• Strong staff coaching and development skills.
• Strong ability to communicate.
• Strong ability to influence in a team environment and collaborate with peers.
• May participate in interactions with various governmental agencies/regulators and external auditors.
• Strong understanding of US FDA regulatory requirements.
• Serves as an active member of the Quality Management Team
• Serves as an expert to identify best practices across the organization, shares and implements as appropriate.
• Interacts with site efforts to ensure consistency in policies and practices.

Job Description:

• Responsible for implementing all QA/QC inspection and testing, as required by specifications or by regulatory requirements and shall be familiar with all aspects of testing required for commercial building including the quality testing requirements of local Authorities such as the Standards, Productivity and Innovation Board (SPRING Singapore)
• Monitor progress and quality of all C&S, Archi, M&E and security system works, including CONQUAS, Green Mark etc to ensure compliance to project and statutory requirements
• Review procedures to improve productivity.
• Attends meetings with client, authorities, subcontractors and consultants.
• Ad-hoc duties as assigned

Requirements (Qualification & Experience):

• Preferably university graduate in Electrical/Security/Computer Engineering or IT recognised by PEB Singapore.
• Ten (10) years of relevant experience in the implementation and management of quality control systems
• Familiar with BIM for construction, Green Mark, CONQUAS and relevant authority requirements
• Full time stationed on site during construction