Total 37 Manager quality assurance engineer job vacancies in 7 Tuas Loop, Singapore

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.

1. Training Program Strategy and Development

• Develop and implement a comprehensive global training strategy aligned with business objectives.
• Design and oversee the development of training programs for various departments, including GMP, quality, regulatory etc.
• Ensure training materials are up-to-date, engaging, and compliant with regulatory requirements.
• Implement innovative training methodologies, including e-learning, virtual reality, and blended learning approaches.
• Select and manage external training vendors and consultants.
• Ensure external training solutions meet company standards and regulatory requirements.

2. Regulatory Compliance

• Ensure all training programs meet GxP requirements and other relevant regulations
• Stay informed about industry trends and regulatory changes affecting pharmaceutical training
• Participate in regulatory inspections and audits related to training

3. Quality Management

• Integrate training initiatives with the company's quality management system
• Develop and maintain SOPs related to training processes
• Implement quality metrics to measure the effectiveness of training programs

4. Learning Management System (LMS) Oversight

• Oversee the implementation and management of the company's LMS
• Ensure proper documentation and tracking of all training activities
• Utilize LMS data to generate reports and analytics for continuous improvement

5. Cross-functional Collaboration

• Collaborate with leadership team to identify and address organizational training needs
• Work closely with Quality Assurance, Regulatory Affairs, Human Resources, and other departments to align training initiatives
• Collaborate with subject matter experts to develop technically accurate training content

6. Budget and Resource Management

• Manage the training department budget
• Lead and mentor a team of training management quality professionals across multiple sites
• Allocate resources effectively across global training initiatives

7. Continuous Improvement

• Regularly assess the effectiveness of training programs and implement improvements
• Stay updated on adult learning theories and innovative training technologies
• Establish forums for knowledge sharing and best practice exchange across global sites

• Manage & develop new customers based for service sales in the industrial, Marine & Offshore/Oil Gas market.
• Responsible for maintaining a high standard level of customer services and good customer relation.
• Responsible for maximizing a high level of profit margin and ensure meeting the pre-set sales target.
• To identifying and developing sales & marketing strategies to exhaust opportunities in the local market as well as to exploit overseas markets.
• Make sales presentation and provide technical support to customer
• Gather information on market demand, competition and latest technologies.
• Submission of weekly, monthly and quarterly reports.

• Manage & develop new customers based for spare part sales in the industrial, Marine & Offshore/Oil Gas market.
• Responsible for maintaining a high standard level of customer services and good customer relation.
• Responsible for maximizing a high level of profit margin and ensure meeting the pre-set sales target.
• Executing sales & marketing strategies to maximize opportunities in both domestic and international markets.
• Make sales presentation and provide technical support to customer
• Gather information on market demand, competition and latest technologies.
• Submission of weekly, monthly and quarterly reports.

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

JOB RESPONSIBILITY

• Find tender opportunities GeBIZE.

• Prepare Tender and submission.

• Familiar with reinstatement and maintenance work.

• Review and analysis of Tenders Drawings & Documentation.

• Preparing Tender submissions and reviewing Procurement & Reviewing of Contracts, and ensuring compliance.

• Reviewing and commercial management of all projects, to ensure accurate and reliable reporting.

• Review all incoming correspondence from Clients, Consultants & Design Team to identify contractually critical items and to initiate replies.

• Estimating a range of projects in a variety of sectors.

• Improve and implement best practice commercial processes and accurate budgeting.

• Maintain accurate records and provide necessary detailed backup to support commercial tracking and costing.

• On Site measurement of Electrical Services.

• Preparation of specialist sub-contract work packages.

• Preparing monthly Commercial Progress reports.

• Other ad-hoc duties assigned by Construction Manager.

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.

WE NEED EXPERICEND FOR METAL WOKS , ALUMINMUM WORKS , WETRADE WORKS AND TILES WORKS FOR CONSTRUCTION (HDB / CONDO ) , NEED HAVE EXCELLENT IN CHINESE AND ENGLISH COMMICATION SKLII AND ACKNOWLEGE DESIGN WORK ,NEED TO GO THROUGH WITH SITE COODINATOR FOR BQ AND MATERAILS ORDER AND DRWAING SUBMISSION WORKS ，ALLOW TO FOLLOW AND COORDINATE WITH SITE WORKS AND PROGRESS WITH MAINCON , SITE MEETING

Responsibilities:

• Tracks and report daily work progress to the Yard Manager
• Ensures that the repair, conversion and construction jobs defined in the Specifications to be performed are carried out in accordance to the budget and schedule set by the Project Manager.
• Appoints approved subcontractors in consultation with Subcontracts Dept and Yard Manager and authorize purchase of equipment, spares and materials
• Ensures that records of work done are copied to the billing and project manager for their follow-up actions
• Responds to customer complaints and take corrective and preventive actions on errors of staff, subcontractors and suppliers
• Implements and maintain the Safety Management and Quality Management Systems.
• Communicate progress, highlights, and prioritizes between Hull Shop and Hull Afloat.
• Carries out special project documentation and case studies including work methods improvements.
• Ensures the safety of personnel through compliance with Occupational Safety and Health and Environmental Regulations.
• Ensures that Health, Safety & Environmental operating procedures are followed and counsel employees about compliance as necessary.

Requirements:

• Diploma or Degree in Marine Engineering/ or related engineering disciplines
• At least 4 years of relevant working experience in FPSO EPC projects
• Ability to read and interpret technical blueprint, plan tools/ equipment/ material take off, prepare project schedule, and input manpower loading
• Willing to go on overseas assignment (2 - 3 months)
• Understands the yard’s various functional systems, ship repair knowledge and related commercial matters.
• Good Degree of planning, organisation, control, problem-solving, decision-making, interpersonal, communication and people management skills required.
• Good knowledge in standards and class requirements on various works in ship repair industry.
• Good knowledge on safety requirements and standards for various works carried out in the yard.
• Possess skill to assess the cost and time required for the additional works.

Our Addresses and Working Hours:

Seatrium (SG) Pte. Ltd.

(Tuas Yard)

Pioneer Sector 1, Singapore 628437

(Islandwide transport provided)

Mon - Thu: 8:00am - 5:15pm

Fri: 8:00am - 4:30pm

Interested candidates are invited to send us an updated resume with your current and expected salary and earliest availability.

We regret that only shortlisted candidates will be notified.

Please note that your personal data disclosed to Seatrium Limited and our group of companies, shall be used for the purposes of evaluation, and processing in accordance with our recruitment processes and policies. By providing your personal data, you have consented to the aforesaid purpose under the provisions of the Personal Data Protection Act 2012.

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.

Job Summary:

Seeking a Sales Manager / Engineer with a civil engineering background and sales experience in construction or building materials. This role involves liaising with consultants, professional engineers, architects, and façade contractors to drive sales and deliver presentations.

Job Responsibilities:

• Develop and execute sales strategies.
• Build relationships with industry professionals.
• Coordinate with the technical team to present aluminum and glass, façade and curtain wall solutions.
• Coordinate with project teams and provide regular sales updates.
• Follow up on claims and payments from clients to ensure timely processing.

Job Requirements:

• Degree in Civil Engineering
• Sales experience in construction / building materials
• Knowledge of façades, curtain walls, and glazing systems is an advantage
• Strong communication and presentation skills

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.

HOW MIGHT YOU DEFY IMAGINATION?

Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring an Senior Manager (Process Development) in Singapore.

Senior Manager (Process Development)

What you will do

The successful candidate will apply subject matter expertise to support technology transfer and ongoing cGMP production of commercial protein biologics processes. Scope of work could include:

• Lead site PD activities for continuous improvement, productivity improvement, and product life cycle management.

• Lead and manage PD safety and compliance initiatives including inspection readiness.

• Manage and oversee PD related projects, ensuring they are completed on time, within scope, and budget. Analyze project outcomes to identify areas for improvement and drive continuous optimization.

• Represent PD on key projects or business processes.Stay abreast of industry trends and leverage expertise to ensure the success of the Amgen Singapore Site, focusing on reliability, efficiency, agility, and differentiation.

• Collaborate with cross-functional teams and network drug substance teams for process alignment by applying advanced technical principles and concepts.

• Site PD champion for digital literacy and new digital tools deployment for process monitoring, tech transfer, and facility modeling. Apply best practices to leverage data for more proactive and predictive approaches.

• Support regulatory filings, audits and inspections, and other CMC activities.

Win

What we expect of you

Basic Qualifications

· Doctorate Degree and 2 years of biologics process development or commercial-scale technical support experience Or

· Master’s Degree and 6 years of biologics process development or commercial-scale technical support experience Or

· Bachelor’s Degree and 8 years of biologics process development or commercial-scale technical support experience

Preferred Qualifications

· 6+ years in a technical role supporting manufacturing processes or 8+ years as a project manager for cross-functional teams within regulated environments (i.e., cGMP)

· Strong oral and verbal communication skills, interact effectively with diverse internal and external (suppliers) stakeholders.

· Knowledgeable in regulatory filings authoring and inspections. Experienced in biopharma product end to end lifecycle management (e.g product team lead).

· Familiarity in MoF single use facility operational aspects of commercial biopharma manufacturing and proficient in big data analysis.

· Working experience with capital / engineering project from early stage to project turnover.

· Stakeholder Communication: Maintain clear and effective communication with all project stakeholders in multicultural working environment, including providing regular updates and managing expectations.

· Agility and Learning: Promote a culture of agility and learning within project teams, encouraging innovation and adaptability in a dynamic business environment.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Responsibilities

1. Work effectively with Operations and Maintenance staff from the Lines as well as other engineering departments to investigate defects. To develop methods, propose modifications and improve maintenance strategies to rectify them.

2. Analyze and trend condition monitoring and defect data to identify reliability concerns. To develop methods, propose modifications and improve maintenance strategies to overcome them.

3. Draft technical work instructions for preventive and corrective maintenance activities.

4. Identify and implement cost-effective technologies to enhance the RTS Signaling, Communication & Control System performance.

5. Support LTA and RTSO projects in reviewing project design specifications and ensure their adequacy for the safety, reliability, maintainability and operability. To provide

other engineering support to the projects, as required.

6. Work in STRC Tuas, Singapore

Qualifications & Work Experience

1. Degree in Electrical & Electronics Engineering or equivalent from recognized institution

2. Previous Railway System experience would be advantageous

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.

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 Summary

The Channel Sales Engineer / Manager will be based in Singapore and will be responsible for developing the channel sales strategy, partnering existing distributors, developing new channels to provide compressed air solutions and grow our channel sales revenue.

He/she will act as an interface between Ingersoll Rand and our distributors in Singapore to drive strategic alignment and resolve outstanding challenges relating to sales, service, and operations.

Responsibilities

• • Develop and execute channel sales strategies for Ingersoll Rand’s Industrial Technology & Services (ITS) compressed air solutions in Singapore.
• Identify and develop new channel partners.
• Perform business analysis (e.g., SWOT) through collection of information from competition, distributors, customer buying behaviour, potential market volume, current market share and customer’s feedback.
• Achieve sales target set for area of responsibilities and industries by building and maintaining close relationships with distributors & customers to solicit for orders.
• Provide pre-sales technical assistance (incl. demonstration & technical presentations), product training and after-sales support to distributors and end-users.
• Report channel sales activities timely and accurately, submit monthly reports on channel sales, lost orders, and competition.
• Attending trade shows, conferences, marketing, and other events.
• Work closely with supply chain management, sales support and project engineer and order fulfilment team.

Basic Qualifications

• Degree / Diploma in Mechanical Engineering or related fields.
• Channel sales experience with industrial products such as Air Compressors, Dryers or other similar equipment.
• Driving license & own vehicle.

Travel & Work Arrangements/Requirements

Office-based, will be required to travel within Singapore or overseas for business needs.

Key Competencies

• Customer Orientation
• Ownership
• Business Awareness

What we Offer

• Equity Grant
• Employee Insurance (Incl. Dependants)
• Medical Health Screening
• Outpatient Medical & Specialist
• Dental
• Annual, Sick, Hospitalisation, Marriage, Exam, Compassionate, Maternity, Volunteerism Leaves.

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.

Job Responsibilities:

1. Assisting and supporting technical sales team in terms of scope of supplies and costing with respect to electrical, automation requirements during the prospecting stage for water/wastewater related systems and projects.
2. Liaising and communicating with agents/distributors/OEM partners/end-user customers on technical details and specifications of parts and components where EICA works are concerned.
3. Design and producing electrical, control panel drawings (AutoCAD or Eplan), BOM list generation and hardware component selection.
4. Developing PLC programming & HMI project (Siemens /Allen Bradley etc) for all process and functional controls of water/wastewater related systems and instrument.
5. Liaising, negotiating, and managing sub-suppliers/sub-contractors in Singapore and in the region with respect to procurements of all wiring and cabling works, fabrication and assembly of control panels for systems as well as for in-situ installation of water/wastewater related systems or projects.
6. Determining and monitoring procurement and production progress and schedules where cabling and wiring works, control panels’ PLC works and supplies are concerned.
7. On site electrical installation supervision, electrical panel testing, instrumentation configuration, loop test and automation commissioning works.
8. Compiling and handing over operation and maintenance (O&M) manuals (electrical and PLC portions etc) to our agents/distributors and end-user customers.

Requirements:

• Diploma / Degree in Electrical Engineering or Computer Science.
• Good Interpersonal relationship and communication skills with proficiency in spoken and written English.
• Minimum 5 to 8 years of working experience in Water Industry or engineering projects would be advantageous.
• Knowledge of PLC programming (Siemens /Allen Bradley etc)
• Willingness to travel locally or to regional countries occasionally for site installation, trouble-shooting or testing and commissioning duties at clients' project sites
• Able to work independently and a good team player.
• Senior position will be considered for candidates with more experience.
• Candidate who are able to start work within short notice or immediately would be advantageous.