Total 21 Manager quality assurance job vacancies in D04 Harbourfront,Telok Blangah, Sentosa Island

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).

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.

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.

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.

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.

Roles & Responsibilities

Job Responsibilities

· Lead and drive the team for continuous improvement on system and process, conduct monthly QPR meeting and review typical quality issues and follow up with team for improvement.

· Work as quality representative of tool room to manage customer audit, ISO audit and internal audit, prepare the team for the audit and subsequent activities.

· Monitor KPI of tool room and attend annual MR meeting to report tool room KPI performance.

· Lead QA/metrology team for inspection activities and work closely with engineering team for tool improvement.

· Study critical characteristic of new product drawing requirement, propose steel safe strategy with past similar tool experience into tooling design.

· Manage customer complaint and attend customer meeting related to quality or metrology issues.

· Monitor supplier quality performance and issue corrective and preventive action report to drive continuous improvements.

· Perform audits on supplier’s process to ensure quality control and quality assurance systems are in place

· Publish tool fabrication quality standards and ensure suppliers understood and comply with the requirements

· Assist in evaluation and qualification of new supplier.

· Other duties as and when assigned by Supervisor or Management

You may be authorized to:

· Contain suspected, non-conforming products and prevent from further processing.

· Stop new orders which do not conform to requirements.

Requirements

· Degree or Diploma in Quality Engineering or relevant

· Minimum 5 years of relevant experience in a plastic injection molding industry

· Knowledge and experience in GD&T, SQC tool

· Certified Internal Auditor for ISO 9001, ISO14001 and ISO 13485.

· Ability to apply problem solving technique and provide solutions under minimal supervision.

· Good written and oral communication skills

· Organized, decisive, logical, Independent and possess leadership, organization and communication skills

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.

Key Responsibilities

• Identify, develop & follow-up on new sales leads for corporate training products and consultancy services.
• Responsible for end-to-end account business planning including research, documentation, account planning and internal coordination to ensure that each account has a clear and actionable plan that best meets the client’s needs.
• Maintain and grow revenue streams by developing and maintaining relationship with clients to ensure maximum revenues generation over the long term.
• Manage delivery of consultancy and training projects including client expectation and satisfaction. Ensures that clients receive products and services to agreed standards of quality and on time by effectively managing and monitoring those who deliver the work and taking corrective action including escalation when necessary to guarantee client satisfaction and sustainable financial results.

Key Requirements

• Bachelor degree in Business Administration, Business Management, Sales & Marketing or closely related field, preferably with past experience in either Human Resource, Quality Management or Organisational Development related work or equivalent experience.
• Prior sales and business development experience in the professional services sector within APAC will be an added advantage. Track record of meeting and exceeding revenue targets.
• Excellent presentation and communication skills and confident in using technology tools to build relationships and engage with clients and prospects.
• A social media presence with a strong follower base will be an added advantage.

• 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.

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.

Job Description

• To plan, manage, oversee and be responsible for all aspects of the health, safety and environmental matters for the Project.

• To advise and report to the Superintending Officer and ensure the Project complies with its statutory obligations, Changi East safety requirements, airport authority's safety requirements and aerodrome safety standards.

• To manage the team of ASMs to ensure all duties and responsibilities required of them are discharged professionally and competently. He shall carry out regular meetings with the team and address any issues relating to their personal and work matters.

Job Requirements

• Minimum 10 years of Workplace Safety and Health (WSH) experience in the construction industry, preferably 5 years with developer/main contractor.

• Minimum 5 years of WSH experience in deep excavation works.

• Minimum 3 years of experience in managing a team of site safety personnel.

• Possess Engineering, Workplace Safety & Health Disciplines, or related qualifications.

• Registered with MOM as a Workplace Safety and Health Officer (WSHO) and has been practising as WSHO for at least 5 years.

• Has obtained certificate in development of a Risk Management Implementation Plan (bizSAFE Level 2) or equivalent.

• Has obtained certificate in DfS appreciation course.

• Good communication skills and a competent team leader

• Conversant with all procedures in Workplace Safety & Health Manual. To make conscious effort to be constantly updated on any subsequent revisions to the above-mentioned manuals, procedures and all applicable airport circulars

Job Description

• Responsible for ensuring that both CAG Employers Information

• Requirements (EIR), LTA Exchange Information Requirements (LTA EIR) and Project BIM Execution Plan (BEP) are implemented on site.

• Responsible for ensuring the capability of Contractors & sub-contractor BIM team are within the EIR documents & to the BEP.

• Responsible for ensuring that all related infrastructure and facilities are

• coordinated in BIM Model before commencement of actual works on Site.

• Responsible for ensuring that all Shop Drawings/Construction drawings are coordinated & updated in BIM Models before commencement of actual works on Site.

Job Requirements

• Minimum 10 years of relevant work experience, highly proficient in the use of BIM software and in establishing required processes and procedures and framework for BIM in projects.

• Familiar with various aspects of engineering e.g. Civil, Structural, Architecture, Mechanical, Electrical.

• Possess a Degree in Engineering / Architecture or equivalent.

• Highly motivated and able to work independently, a strong team player and able to handle fast-paced projects.

• Possess good interpersonal, written and verbal communication skills for collaboration with stakeholders across all levels and have good presentation skills.

• Shall be continuously under employment under any Consultant/Contractor for a minimum of 5 years and have successfully

• Instituted a BIM Company Deployment Plan as well as implemented Project BIM Execution Plan for at least 2 projects.

• Completed a certification course in BIM Management.

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.

What a System Quality Program Manager does at HP:

Manage Quality Programs:

• Lead quality assurance programs from initiation through closure, ensuring alignment with project scope, goals, and deliverables.
• Oversee all aspects of quality program management, including planning, budget and resource control.
• Conduct System At Glance Test, Workflow Duration Test, and Continuous Regression Test.
• Support priority test projects with direction, maintaining relationships with internal stakeholders and sharing information with testers via standardized reports and regular stand-up meetings.

Collaborate with Cross-Functional Teams:

• Work closely with cross-functional teams to define program requirements, identify risks, and ensure successful project execution within defined timelines, resources and budgets.

Execute Quality Assurance Plans:

• Define and manage comprehensive test plans to ensure HP Print ecosystem integration quality.
• Oversee test coverage, schedules, and resource adjustments to meet program objectives.

Monitor and Analyse Quality Metrics:

• Track quality metrics to ensure compliance with HP’s standards, conduct data analysis to identify improvement areas, and drive continuous improvement initiatives.
• Lead Data-Driven Decision Making.

Facilitate Communication:

• Act as a primary quality contact for stakeholders, communicating program status, risks, and escalations effectively.
• Prepare and maintain QA-related documentation, including test plans, test matrices, and testing reports.
• Provide regular updates and insights to senior management.

Encourage a Culture of Innovation and Continuous Improvement:

• Promote a collaborative environment, integrating new technologies and quality methodologies, and driving process enhancements.

Individuals who do well in this role at HP, usually possess:

• Four-year Degree in Computer Science, Software Engineering, Information Systems, Information Technology, or any other related discipline or commensurate work experience or demonstrated competence.
• Typically has 0-1 years of work experience, preferably in software quality assurance, test harnesses and QA focused tools, or a related field.
• Good to have skills and knowledge: Agile Methodology, CI/CD, Computer Science, JIRA, Scrum (Software Development), Software Development, Software Engineering, Software Quality (SQA/SQC), Software Testing.
• Test Planning, Knowledge in Quality and defect management.
• Any certifications are a plus: Project Management Professional (PMP) Certification, Lean Six Sigma Certification or equivalent quality certifications, Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), Certified Software Quality Engineer, Certified Associate in Software Quality (CASQ), Certified Software Test Engineer (CSTE).

Sustainable impact is HP’s commitment to create positive, lasting change for the planet, its people, and our communities. This serves as a guiding principle for delivering on our corporate vision – to create technology that makes life better for everyone, everywhere.

HP is a Human Capital Partner – we commit to human capital development and adopting progressive workplace practices in Singapore.

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

Job Description:

• Building & Demolition projects

• Restoration and Refurbishment Works

• Additions and Alteration Works

• Driving IDD implementation for the works

Job Requirements:

• Degree in Architecture, Civil & Structural Engineering, Mechanical & Electrical Engineering, Building Science or Quantity Surveying from a University recognized by the respective Professional Bodies or Professional Institutions.

• Minimum 5 years of practical experience in the design and/or construction management of construction projects with contract value of $5 million and above.

Job Description:

• Infrastructure works like roads, drains, sewer works and ancillary works;

• Rectification of infrastructure works such as roads, drains, sewers and ancillary works for handing over to authorities;

• Provision of amenities such as footpaths/pavements, Personal Mobility Device (PMD) tracks, cycling paths, sheltered linkways, decking, etc;

• Construction of surface parking for cars, buses, heavy vehicles;

• Road traffic and junction improvements such as installation of road signage, lane markings;

• Construction of bus stops, bus bays, pedestrian overhead bridges and associated works;

• Earthworks and disposal of debris, removal of stockpiles and other unusable material;

• Slope protection and rectification, Trial trench works;

• Minor land clearances and clearing of overgrown vegetation;

• Instrumentation & Monitoring

Job Requirements:

• Degree in Civil & Structural Engineering from a University recognized by the Professional Engineers Board (PEB) and/or accreditation recognized by the Professional Engineers Board.

• At least 5 years of practical experience in the management of building (e.g. new building, R&R and A&A projects) or infrastructure (e.g. road, drain, sewers, services diversion) projects with contract value of $5 million and above.

• The PM must be familiar with PSSCOC.

• At least 2 years of relevant working experience or involvement in Integrated Digital Delivery (IDD) for project delivery and built environment industry.

• Strong, mature and proven ability to organize, manage and motivate a project team.

Job Description:

• Infrastructure works like roads, drains, sewer works and ancillary works;

• Rectification of infrastructure works such as roads, drains, sewers and ancillary works for handing over to authorities;

• Provision of amenities such as footpaths/pavements, Personal Mobility Device (PMD) tracks, cycling paths, sheltered linkways, decking, etc;

• Construction of surface parking for cars, buses, heavy vehicles;

• Road traffic and junction improvements such as installation of road signage, lane markings;

• Construction of bus stops, bus bays, pedestrian overhead bridges and associated works;

• Earthworks and disposal of debris, removal of stockpiles and other unusable material;

• Slope protection and rectification, Trial trench works;

• Minor land clearances and clearing of overgrown vegetation;

• Instrumentation & Monitoring

Job Requirements:

• Degree in Civil & Structural Engineering from a University recognized by the Professional Engineers Board (PEB) and/or accreditation recognized by the Professional Engineers Board.

• At least 5 years of practical experience in the management of building (e.g. new building, R&R and A&A projects) or infrastructure (e.g. road, drain, sewers, services diversion) projects with contract value of $5 million and above.

• The PM must be familiar with PSSCOC.

• At least 2 years of relevant working experience or involvement in Integrated Digital Delivery (IDD) for project delivery and built environment industry.

• Strong, mature and proven ability to organize, manage and motivate a project team.

Job Description:

• Drive PGCS Quality programs and policies compliance across site, by partnership with functional stakeholders.
• Key contributor/promoter to the advancement of Quality function across the sites; creating and driving critical/key business objectives in line with supporting/partnering with Operations, Supply Chain functions etc.
• Lead incident management and resolution and champion customer quality across Singapore. Site lead for Quality and Food safety crisis mgmt.
• Lead the implementation of the Singapore Quality Strategy including communication, project management and roll out activities.
• Lead continuous improvement culture/productivity initiatives to support site BPI process, demonstrating best practices to implement all quality improvements
• Drive, support and champion KPIs, key Quality metrics, etc.
• Act as a business partner to other functions whilst championing Quality, to ensure an extended and consistent quality focus.
• Be a key member of the Site Leadership team and value add in driving functional and site agenda.
• Support and provide strategic guidance around NPIs, validation, Total Quality System, Compliance, Capital investment, etc.
• Partnership with other functions ensuring change control risk assessment and validation in place for Network capacity projects and other key projects and significant changes.
• Financial Management; Budgetary and AOP responsibilities/input.
• Compliance; drive partnership with other functions through the Quality team to achieve key business goals for the control environment. Compliance with all regulations and 3rd party auditing requirements.
• Provide strategic quality leadership to the extended Quality Team
• Organisation design & sustainability of a highly effective team with appropriate succession plan. Encourage, manage & promote people-related activities/processes, partnering with HR
• Develop capability, personal growth and career development for direct reports, support these activities with DRs’ associated teams.
• Play in instrumental role in developing the overall team capability, supporting and aligning with overall plant culture.
• Ensure the smooth transition of new products to the Singapore facilities.
• Manage the complexity of additional materials, packaging and concentrate components from a quality perspective as portfolio expands
• Support and implement PGCSSC global quality initiatives
• Systems improvements (including IT systems) in terms of Processing, GMP, Product Safety, Disposition and Traceability.
• A requirement of the role is that you must adhere to all PepsiCo Health & Safety requirements.

Qualifications :

• Bachelor’s Degree in Science, Food Technology, Chemistry or any other related discipline
• Minimum 7 years of relevant experience as a supervisor in operating Laboratory environment, manufacturing concern/MNC
• Ability to manage senior stakeholders and leadership team members
• Experience in People Management and prior supervisory skill
• Possess knowledge of and experience in GLP, HPLC / GC operation, SAP QM module and LIMS management
• Strong leadership presence, ability to manage and co-ordinate with cross-functional teams on investigation analysis, troubleshooting and issues resolution
• Knowledge of food safety quality standards such as HACCP and FSSC 22000
• Ability to lead change and drive behaviours
• Ability to organize and manage multiple priorities in high-pressure work environment
• Strong collaboration and influencing skills
• Excellent communication and interpersonal skills, both verbal and written with ability to clearly articulate ideas and proposals to all levels of the organization
• Positive and Can-do Attitude
• Willing to stretch and take additional responsibilities when needed
• Lead by example to others

Kindly note that this is a short-term role based in Singapore.

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.

This is an exciting position who is responsible for QA oversight of Aseptic Processing Program, Environmental Monitoring and Microbial Control Policies for the Cell and Gene Therapy entity. Role will provide oversight and sterility assurance expertise to Operations to assure aseptic processing meets US and international aseptic processing requirements ( FDA Sterile Product Aseptic Processing Guidance and Eudralex, Annex 1,” Sterile Medicinal Drug Products”, ISO 13408 and 21CFR820).

The role will also provide strategic plan and expertise for the development and implementation of the Microbial Control Strategy. Develop, document and manage microbial control strategy for production processes from incoming raw materials through final product release.

Key responsibilities:

• Provide support and expertise to ensure that Cell and Gene Therapy (CGT) and Media preparation operations and support functions for Cleanroom management, Materials Management, Aseptic practices, Environmental monitoring (EM). Sterilisation methods, and Aseptic process simulations (APS) to confidently deliver CT products to patients with the highest quality sterility assurance level.
• Review policies and procedures and related completed media fill/APS documentation, Environmental Monitoring sample plans, cleanroom qualifications, environmental monitoring excursions, deviations and sterility failures.
• Provide Sterility assurance expertise to support APS/EM deviations and investigations, CAPAs and Complaints related to aseptic processing.
• Review of sterile filter validations, integrity testing and procedures.
• Provide expert support and assessment to business partners including production, MSAT, Engineering, QC and QA assuring adequate facilities contamination prevention practices, monitoring tools are provided to production to guarantee the best EM indicator levels.
• Involvement in global harmonization/ efficiency projects; begin to lead aspects of global projects within specific areas.
• Represent site in global forums from sterility assurance perspective. Collaborate with stakeholders of different functions to lead/implement various global/site projects to support sterility assurance.
• Support regulatory and client audits as Aseptic sterility assurance subject matter expert
• Responsible for the generation of key performance indicators, GEMBA walks, regulatory compliance and efficiency targets.
• Communicate quality operations and compliance perspective effectively to senior management.
• Understand and articulate company business strategy. Maintains a broad view of the business recognizes changes and trends in the appropriate area in which the individual operates.

Key requirements:

• Engineering/ Life Science Diploma/Degree or higher from recognized institution with significant years of QA or QC Sterile processing and Microbial experience in similar capacity.
• GMP experience in the biologics industry is required.
• Working knowledge of microbiological and sterility testing, media fills, environmental monitoring , clean room qualification and management, quality control endotoxin testing and microbiological control strategy required.
• Experience with oversight of aseptic processing and the associated international aseptic processing regulations are required.
• Experience in cell culture, cell or gene therapy experience is a plus.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

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