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The Head of Quality oversees and directs all QA and QC activities to ensure that pharmaceutical products are developed, manufactured, and released according to stringent regulatory standards. The position is accountable for strategic leadership, regulatory compliance, GMP adherence, and continuous improvement, ensuring patient safety and product efficacy throughout the lifecycle. This is a greenfield pharmaceutical startup.
Responsibilities
Strategic and Regulatory Leadership
Establish, implement, and maintain robust quality management systems (QMS) aligned with cGMP, GLP, ICH guidelines, and other applicable standards (FDA, EMA, PIC/S, & HSA).
Set and communicate a clear quality strategy; ensure widespread understanding across the organization.
Serve as lead company representative during regulatory and certification audits/inspections, including FDA, EMA, MHRA, and local authorities.
Oversee quality system documentation, including SOPs, protocols, batch records, validation, and change control.
Quality Assurance (QA)
Lead all QA programs, including batch record review, final product release, CAPA, deviations, and risk management.
Continuously monitor compliance with GMP and quality regulations across facilities, personnel, and processes.
Conduct internal and supplier audits; ensure readiness for any external inspection.
Guide root cause analyses, continuous improvement efforts, and remediation plans in the event of non-conformities.
Quality Control (QC)
Oversee all QC operations, ensuring testing of raw materials, in-process samples, finished products, process validation, and environmental monitoring is timely and accurate.
Approve QC policies, test methods, and specifications ensuring validity and compliance.
Ensure appropriate investigation and resolution of OOS (out of specification) and OOT (out of trend) results.
Ensure all testing and reporting meet regulatory and company requirements for data integrity.
Lead, mentor, and motivate QA and QC teams; set clear objectives, conduct appraisals, and deliver ongoing training.
Develop a culture of accountability, quality, and operational excellence.
Oversee training programs to ensure compliance with current GMP, SOPs, and regulatory expectations.
Continuous Improvement and Reporting
Set, monitor, and report on key quality KPIs—CAPA effectiveness, audit outcomes, compliance rates, batch release turnaround, documentation compliance, and training completion.
Drive process improvements through risk assessments and proactive change management.
Qualifications
Bachelor’s or Master’s in Pharmacy, Chemistry, Life Sciences, or related field.
Minimum 10 years in pharmaceutical QA/QC, including 5+ in senior leadership.
Extensive knowledge of cGMP, GLP, GCP, ICH Q7/Q8/Q9/Q10, and international regulatory requirements.
History of successful regulatory inspections (e.g., FDA, EMA, HSA), audit leadership, and operational excellence.
Required Skills
Expert understanding of pharmaceutical regulations, QMS, and data integrity.
Strong leadership, organizational, team development, and communication skills.
Analytical, decisive, and solution-oriented with attention to detail.
Skilled in process improvement, problem-solving, risk management, and change control.
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Roles & Responsibilities

The Engineer II, Quality Control (QC), is responsible for all aspects of incoming and in-process quality planning, inspection, metrology, and incoming inspection operations. This role ensures the achievement of quality objectives, operational targets, and product quality requirements while serving as the subject matter expert for metrology development and issue resolution, including alignment between internal and supplier metrology processes.

The Engineer II, Quality Control (QC), plays a pivotal role in overseeing and improving supplier quality management processes. This position is responsible for ensuring that suppliers meet compliance standards and driving continuous improvements in their quality performance. The SQE will focus on monitoring, analyzing, and enhancing the quality of materials received, ensuring they meet organizational standards and customer requirements.

Your Responsibilities

Incoming Inspections

• Ensure Process Compliance: Oversee inspection and operational processes to ensure adherence to established procedures, work instructions, drawings, and specifications.
• Develop Test Specifications and Programs: Create test specifications and measurement programs for geometric and non-geometric tests, including material testing devices (e.g., tensile-testing).
• Support Fixture and Jig Design: Collaborate with internal and external service providers to design and construct fixtures and jigs, including concept development and requirement specification creation.
• Validate Measurement Procedures: Perform method validation and verification of measurement procedures in compliance with existing regulations and guidelines, including conducting GR&R (Gauge R&R) and process capability studies.
• Manage Test Equipment Selection and Procurement: Identify appropriate measuring and test equipment and support the procurement process to meet operational needs.
• Integrate Testing Systems: Implement data transfer of measuring and testing devices into the SAP QM system, ensuring seamless interface support as required.
• Streamline Incoming Material Processing: Ensure timely processing of incoming materials by optimizing inspection activities for efficiency and accuracy.
• Manage Non-Conforming Materials: Oversee incoming rejection processes for non-conforming materials, monitor aging periods, and implement actions to minimize delays and inventory impact.
• Collaborate on Inspection Requirements: Work with the quality or engineering team to define incoming inspection and metrology requirements for new products and raw components.
• Analyze and Report Quality Performance Data: Lead quality inspection performance data analysis, establish KPI metrics, and report findings to drive improvements.
• Execute Quality Projects and Tasks: Support and execute quality-related projects, tasks, and other activities as directed by the supervisor.

Supplier Quality Management

• Coordinate and work on the Supplier Selection process for new project development and qualification of new and or alternate supplier, to ensure that the right supplier is selected based on the defined requirements and specifications.
• Supports and or lead the conceptualized bill of materials creation together with relevant functions for new product development.
• Resolve supplier-related quality issues by ensuring timely and effective resolutions to maintain continuity of supply. Proactively collaborate with suppliers to identify opportunities for improvement, implement controls, and enhance the quality of received materials.
• Oversee Supplier Quality Management activities, including generating quality reports, conducting supplier assessments and qualifications, managing SCARs, reviewing supplier change notifications, approving first articles, maintaining supplier scorecards, and driving supplier development plans.
• Support suppliers change requests and qualification initiatives, including new parts, revisions, and tooling changes, to ensure seamless integration into the supply chain.
• Review and approve supplier control plans and inspection standards to ensure alignment with company quality objectives.
• Ensure timely resolution of supplier quality issues, including implementing corrective and preventive actions to address root causes effectively.
• Drive measurable improvement initiatives to enhance supplier performance, ensuring consistent excellence in supplier scorecards and quality metrics.
• Establish and maintain Supplier Quality Agreements, ensuring clarity in expectations and adherence to standards.
• Lead supplier audits (desktop, remote, or onsite) as part of the Global Supplier Audit program by developing comprehensive audit agendas, conducting thorough evaluations, preparing detailed supplier audit reports, and ensuring supplier adherence to quality and regulatory standards.
• Implement productivity improvement initiatives in collaboration with suppliers to enhance their quality output performance and improve the efficiency of incoming inspection processes.
• Collaborate with the Incoming QA team of inspectors and technicians to address incoming inspection issues and manage rejections by coordinating with suppliers to resolve non-conformances effectively.
• Plan and sustain the reduced incoming inspection activities by working closely with the suppliers to establish their outgoing inspection and monitor its performance.
• Provide key supplier performance metric updates to management, offering actionable insights into supplier and material quality performance.
• Support and execute quality-related projects and tasks as directed by the supervisor, ensuring alignment with organizational goals and objectives.
• May act as the strategic regional supplier quality representative to support other sites.

Your Profile

• Technical / scientific degree at college / university level (mechanical, mechatronic engineering or equivalent)
• 5-7 years of relevant experience in Quality Control, preferably within a regulated environment.
• Expert knowledge in quality inspection techniques, quality tools, failure mode analysis, and extensive experience in handling measuring instruments.
• Proven experience in calibrating and maintaining quality control equipment to ensure accuracy and reliability.
• Familiarity with metrology equipment, including Coordinate Measuring Machines (CMM), Smart Scope, Height Gage, Vernier Calipers, Digital Micrometers, measuring tapes, protractors, thread plug gages, and Profile Projectors.
• Strong ability to interpret technical drawings and apply Geometric Dimensioning and Tolerancing (GD&T) principles effectively.
• In depth know-how of QMS regulations: ISO 13485, 21 CFR 820, ISO 14971, or applicable local regulations.
• ISO 9001/13485 auditor experiences or certification
• Statistical methods
• Technical knowledge and experience to work effectively with cross functional teams. (Operations, R&D, Facility Management, HR, Procurement, Finance), is preferred.
• Good communication skills with people from all levels in the organization
• SAP and Success Factor User experience is a plus

Interest applicants, pls email updated resume to

Jessie Hoe Huey Miin

CEI Reg No. R

EA Lic: 99C4599

Roles & Responsibilities

The Engineer II, Quality Control (QC), is responsible for all aspects of incoming and in-process quality planning, inspection, metrology, and incoming inspection operations. This role ensures the achievement of quality objectives, operational targets, and product quality requirements while serving as the subject matter expert for metrology development and issue resolution, including alignment between internal and supplier metrology processes.

The Engineer II, Quality Control (QC), plays a pivotal role in overseeing and improving supplier quality management processes. This position is responsible for ensuring that suppliers meet compliance standards and driving continuous improvements in their quality performance. The SQE will focus on monitoring, analyzing, and enhancing the quality of materials received, ensuring they meet organizational standards and customer requirements.

Your Responsibilities

Incoming Inspections

• Ensure Process Compliance: Oversee inspection and operational processes to ensure adherence to established procedures, work instructions, drawings, and specifications.
• Develop Test Specifications and Programs: Create test specifications and measurement programs for geometric and non-geometric tests, including material testing devices (e.g., tensile-testing).
• Support Fixture and Jig Design: Collaborate with internal and external service providers to design and construct fixtures and jigs, including concept development and requirement specification creation.
• Validate Measurement Procedures: Perform method validation and verification of measurement procedures in compliance with existing regulations and guidelines, including conducting GR&R (Gauge R&R) and process capability studies.
• Manage Test Equipment Selection and Procurement: Identify appropriate measuring and test equipment and support the procurement process to meet operational needs.
• Integrate Testing Systems: Implement data transfer of measuring and testing devices into the SAP QM system, ensuring seamless interface support as required.
• Streamline Incoming Material Processing: Ensure timely processing of incoming materials by optimizing inspection activities for efficiency and accuracy.
• Manage Non-Conforming Materials: Oversee incoming rejection processes for non-conforming materials, monitor aging periods, and implement actions to minimize delays and inventory impact.
• Collaborate on Inspection Requirements: Work with the quality or engineering team to define incoming inspection and metrology requirements for new products and raw components.
• Analyze and Report Quality Performance Data: Lead quality inspection performance data analysis, establish KPI metrics, and report findings to drive improvements.
• Execute Quality Projects and Tasks: Support and execute quality-related projects, tasks, and other activities as directed by the supervisor.

Supplier Quality Management

• Coordinate and work on the Supplier Selection process for new project development and qualification of new and or alternate supplier, to ensure that the right supplier is selected based on the defined requirements and specifications.
• Supports and or lead the conceptualized bill of materials creation together with relevant functions for new product development.
• Resolve supplier-related quality issues by ensuring timely and effective resolutions to maintain continuity of supply. Proactively collaborate with suppliers to identify opportunities for improvement, implement controls, and enhance the quality of received materials.
• Oversee Supplier Quality Management activities, including generating quality reports, conducting supplier assessments and qualifications, managing SCARs, reviewing supplier change notifications, approving first articles, maintaining supplier scorecards, and driving supplier development plans.
• Support suppliers change requests and qualification initiatives, including new parts, revisions, and tooling changes, to ensure seamless integration into the supply chain.
• Review and approve supplier control plans and inspection standards to ensure alignment with company quality objectives.
• Ensure timely resolution of supplier quality issues, including implementing corrective and preventive actions to address root causes effectively.
• Drive measurable improvement initiatives to enhance supplier performance, ensuring consistent excellence in supplier scorecards and quality metrics.
• Establish and maintain Supplier Quality Agreements, ensuring clarity in expectations and adherence to standards.
• Lead supplier audits (desktop, remote, or onsite) as part of the Global Supplier Audit program by developing comprehensive audit agendas, conducting thorough evaluations, preparing detailed supplier audit reports, and ensuring supplier adherence to quality and regulatory standards.
• Implement productivity improvement initiatives in collaboration with suppliers to enhance their quality output performance and improve the efficiency of incoming inspection processes.
• Collaborate with the Incoming QA team of inspectors and technicians to address incoming inspection issues and manage rejections by coordinating with suppliers to resolve non-conformances effectively.
• Plan and sustain the reduced incoming inspection activities by working closely with the suppliers to establish their outgoing inspection and monitor its performance.
• Provide key supplier performance metric updates to management, offering actionable insights into supplier and material quality performance.
• Support and execute quality-related projects and tasks as directed by the supervisor, ensuring alignment with organizational goals and objectives.
• May act as the strategic regional supplier quality representative to support other sites.

Your Profile

• Technical / scientific degree at college / university level (mechanical, mechatronic engineering or equivalent)
• 5-7 years of relevant experience in Quality Control, preferably within a regulated environment.
• Expert knowledge in quality inspection techniques, quality tools, failure mode analysis, and extensive experience in handling measuring instruments.
• Proven experience in calibrating and maintaining quality control equipment to ensure accuracy and reliability.
• Familiarity with metrology equipment, including Coordinate Measuring Machines (CMM), Smart Scope, Height Gage, Vernier Calipers, Digital Micrometers, measuring tapes, protractors, thread plug gages, and Profile Projectors.
• Strong ability to interpret technical drawings and apply Geometric Dimensioning and Tolerancing (GD&T) principles effectively.
• In depth know-how of QMS regulations: ISO 13485, 21 CFR 820, ISO 14971, or applicable local regulations.
• ISO 9001/13485 auditor experiences or certification
• Statistical methods
• Technical knowledge and experience to work effectively with cross functional teams. (Operations, R&D, Facility Management, HR, Procurement, Finance), is preferred.
• Good communication skills with people from all levels in the organization
• SAP and Success Factor User experience is a plus

Interest applicants, pls email updated resume to

Jessie Hoe Huey Miin

CEI Reg No. R

EA Lic: 99C4599

Roles & Responsibilities

The Engineer II, Quality Control (QC), is responsible for all aspects of incoming and in-process quality planning, inspection, metrology, and incoming inspection operations. This role ensures the achievement of quality objectives, operational targets, and product quality requirements while serving as the subject matter expert for metrology development and issue resolution, including alignment between internal and supplier metrology processes.

The Engineer II, Quality Control (QC), plays a pivotal role in overseeing and improving supplier quality management processes. This position is responsible for ensuring that suppliers meet compliance standards and driving continuous improvements in their quality performance. The SQE will focus on monitoring, analyzing, and enhancing the quality of materials received, ensuring they meet organizational standards and customer requirements.

Your Responsibilities

Incoming Inspections

• Ensure Process Compliance: Oversee inspection and operational processes to ensure adherence to established procedures, work instructions, drawings, and specifications.
• Develop Test Specifications and Programs: Create test specifications and measurement programs for geometric and non-geometric tests, including material testing devices (e.g., tensile-testing).
• Support Fixture and Jig Design: Collaborate with internal and external service providers to design and construct fixtures and jigs, including concept development and requirement specification creation.
• Validate Measurement Procedures: Perform method validation and verification of measurement procedures in compliance with existing regulations and guidelines, including conducting GR&R (Gauge R&R) and process capability studies.
• Manage Test Equipment Selection and Procurement: Identify appropriate measuring and test equipment and support the procurement process to meet operational needs.
• Integrate Testing Systems: Implement data transfer of measuring and testing devices into the SAP QM system, ensuring seamless interface support as required.
• Streamline Incoming Material Processing: Ensure timely processing of incoming materials by optimizing inspection activities for efficiency and accuracy.
• Manage Non-Conforming Materials: Oversee incoming rejection processes for non-conforming materials, monitor aging periods, and implement actions to minimize delays and inventory impact.
• Collaborate on Inspection Requirements: Work with the quality or engineering team to define incoming inspection and metrology requirements for new products and raw components.
• Analyze and Report Quality Performance Data: Lead quality inspection performance data analysis, establish KPI metrics, and report findings to drive improvements.
• Execute Quality Projects and Tasks: Support and execute quality-related projects, tasks, and other activities as directed by the supervisor.

Supplier Quality Management

• Coordinate and work on the Supplier Selection process for new project development and qualification of new and or alternate supplier, to ensure that the right supplier is selected based on the defined requirements and specifications.
• Supports and or lead the conceptualized bill of materials creation together with relevant functions for new product development.
• Resolve supplier-related quality issues by ensuring timely and effective resolutions to maintain continuity of supply. Proactively collaborate with suppliers to identify opportunities for improvement, implement controls, and enhance the quality of received materials.
• Oversee Supplier Quality Management activities, including generating quality reports, conducting supplier assessments and qualifications, managing SCARs, reviewing supplier change notifications, approving first articles, maintaining supplier scorecards, and driving supplier development plans.
• Support suppliers change requests and qualification initiatives, including new parts, revisions, and tooling changes, to ensure seamless integration into the supply chain.
• Review and approve supplier control plans and inspection standards to ensure alignment with company quality objectives.
• Ensure timely resolution of supplier quality issues, including implementing corrective and preventive actions to address root causes effectively.
• Drive measurable improvement initiatives to enhance supplier performance, ensuring consistent excellence in supplier scorecards and quality metrics.
• Establish and maintain Supplier Quality Agreements, ensuring clarity in expectations and adherence to standards.
• Lead supplier audits (desktop, remote, or onsite) as part of the Global Supplier Audit program by developing comprehensive audit agendas, conducting thorough evaluations, preparing detailed supplier audit reports, and ensuring supplier adherence to quality and regulatory standards.
• Implement productivity improvement initiatives in collaboration with suppliers to enhance their quality output performance and improve the efficiency of incoming inspection processes.
• Collaborate with the Incoming QA team of inspectors and technicians to address incoming inspection issues and manage rejections by coordinating with suppliers to resolve non-conformances effectively.
• Plan and sustain the reduced incoming inspection activities by working closely with the suppliers to establish their outgoing inspection and monitor its performance.
• Provide key supplier performance metric updates to management, offering actionable insights into supplier and material quality performance.
• Support and execute quality-related projects and tasks as directed by the supervisor, ensuring alignment with organizational goals and objectives.
• May act as the strategic regional supplier quality representative to support other sites.

Your Profile

• Technical / scientific degree at college / university level (mechanical, mechatronic engineering or equivalent)
• 5-7 years of relevant experience in Quality Control, preferably within a regulated environment.
• Expert knowledge in quality inspection techniques, quality tools, failure mode analysis, and extensive experience in handling measuring instruments.
• Proven experience in calibrating and maintaining quality control equipment to ensure accuracy and reliability.
• Familiarity with metrology equipment, including Coordinate Measuring Machines (CMM), Smart Scope, Height Gage, Vernier Calipers, Digital Micrometers, measuring tapes, protractors, thread plug gages, and Profile Projectors.
• Strong ability to interpret technical drawings and apply Geometric Dimensioning and Tolerancing (GD&T) principles effectively.
• In depth know-how of QMS regulations: ISO 13485, 21 CFR 820, ISO 14971, or applicable local regulations.
• ISO 9001/13485 auditor experiences or certification
• Statistical methods
• Technical knowledge and experience to work effectively with cross functional teams. (Operations, R&D, Facility Management, HR, Procurement, Finance), is preferred.
• Good communication skills with people from all levels in the organization
• SAP and Success Factor User experience is a plus

Interest applicants, pls email updated resume to

Jessie Hoe Huey Miin

CEI Reg No. R

EA Lic: 99C4599

QC Systems Analyst (Quality Control, Pharmaceutical MNC, GMP, Medical)
Singapore | Posted: Nov 19, 2024
Position Overview
Carries out quality control functions related to the manufacture, testing, and release of investigational products used in Phase I/II/III clinical studies. Responsible for the inspection, sampling and disposition of raw materials used in the manufacture of drug products. Conducts investigations and determines corrective actions of process and product deviations. Requires an ability to function effectively under timeline pressure and to provide solutions to a wide range of problems.
Main Areas of Responsibilities
• Investigates and resolves laboratory incidents.

• Performs the quality assurance review and approval of laboratory investigation reports including out-of-specification reports.
• Determines if corrective and preventative actions are adequate and evaluates the impact on materials.
• Performs quality assurance review and approval of analytical procedures for compliance with company policies, ICH and regional requirements.
• Assists in the preparation of quality agreements and performs periodic supplier evaluations to ensure compliance with regulatory requirements and company policies.
• Performs incoming quality control inspection of raw materials to ensure compliance to specifications and departmental procedures.
• Performs sampling of raw materials and coordinates with production planners and testing laboratories to ensure raw materials are tested and retested at the required inspection intervals.
• Tracks the status of raw materials from time of receipt to disposition.
• Manages the status and disposition of raw materials in SAP, including the retest/expiration dates of released raw materials.
• Performs sampling of the purified water system used in laboratory operations.
• Reviews water system trend reports and assists in identifying potential root causes of out-of-specification and out-of-trend results.
• Manages the clinical supply operations logbook system and performs the quality review of records to ensure compliance to company procedures and cGMPs.

Requirements
• Good knowledge of cGMP pharmaceutical manufacturing and inspection requirements of pharmaceutical products.

• Interpreting multiple standards and applying them to department activities.
• Detail oriented with proven organizational skills.
• Handling a wide variety of tasks under time constraints.
• Interpreting and evaluating data and summarizing results.
• Good interpersonal skills with team player orientation,
• Min Degree in Science or equivalent with at least 2 years of relevant experience in the pharmaceutical / chemical industry.
• Experience in operating laboratory equipment such as HPLC, GC , KF Titrators.
• Working knowledge of cGMP and regulatory requirements related to Quality is an advantage
• 5 days office hours

If you are interested in the position, do kindly drop your most updated resume to leonleong
@recruitexpress.com.sg
(Attn: QC Systems Analyst)
Thank You.
Recruiter's Ref Code: #HDC
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599
#J-18808-Ljbffr

We are seeking an experienced Senior Pharmaceutical Manufacturing Expert to join our team.

• Minimum of 5-8 years' experience in a similar role, ideally in the Pharmaceutical industry.
• Recipe Authoring, eBRS Development, Equipment Management Aspentech MES
• IP21 Historian experience
• Experience with Aspentech
• Strong understanding of Pharmaceutical process
• Understanding of L2 interfaces and integration with MES
• Familiarity with SDLC and quality management processes in the pharma

• Ability to work well in a team environment.
• Able to manage multiple party coordination for MES information.

• Troubleshooting
• Analytical Skills
• Quality Management
• Agile
• SDLC
• Risk Management
• Information Technology
• SQL
• SAP
• Consulting
• Team Player
• Java
• Business Development

• MES
  Pharmaceutical Industry
  Management Skills

The ideal candidate will have a strong background in Pharmaceutical manufacturing and experience working with Aspentech. A degree in a relevant field is required.

Act as the contact point for local medical gases and medical devices safety issues within normal business hours. If LVO holds the role as local QPPV, LVOs must be reachable 24 hours/day, 7 days/week.
Implementing pharmacovigilance (PV) and medical device vigilance according to the local vigilance standard operating procedure which is developed based on the local and global vigilance requirement.
Work with OS QRA in maintaining the local Vigilance system.
Pharmacovigilance Processes
Notifying Global Pharmacovigilance (PV) Management
Quality Incident Management
Reconciliation and self -assessment
Public Adverse Event Reporting
Agency Reporting
Periodic Safety Update Reports
Risk Management Plan
Global Vigilance Audit by Global Assessment
Third-Party Healthcare Contractors Vigilance Audit
Inspection (Audit performed by authorities
Requirements
At least 2 years in Pharma / Healthcare doing Quality /ISO /GMP
University degree in a technical discipline (engineering preferred)
Post-graduate development programs, e.g., quality systems, change management, problem solving tools, project management.
Healthcare manufacturing processes and knowledge preferred.
Excellent interpersonal and presentation skills in order to communicate effectively with customers and senior management.
Location: Jurong Island (100% onsite)
(The company transport picks up at lakeside MRT, morning 7.45am & 7.55am, evening 5.35pm & 5.45pm)
Working hours: 8.30am to 5.30pm (Mondays to Fridays); with 1-hour lunch break.
Salary: $4K to 5.5K max per month + 250 site allowance + 1.5 month completion bonus + 14 days AL + $00 medical + 1000 specialist per year
Interest applicants, pls email updated resume to
Jessie Hoe Huey Miin
CEI Reg No. R
EA Lic: 99C4599
#J-18808-Ljbffr

Act as the contact point for local medical gases and medical devices safety issues within normal business hours. If LVO holds the role as local QPPV, LVOs must be reachable 24 hours/day, 7 days/week.
Implementing pharmacovigilance (PV) and medical device vigilance according to the local vigilance standard operating procedure which is developed based on the local and global vigilance requirement.
Work with OS QRA in maintaining the local Vigilance system.
Pharmacovigilance Processes
Notifying Global Pharmacovigilance (PV) Management
Quality Incident Management
Reconciliation and self -assessment
Public Adverse Event Reporting
Agency Reporting
Periodic Safety Update Reports
Risk Management Plan
Global Vigilance Audit by Global Assessment
Third-Party Healthcare Contractors Vigilance Audit
Inspection (Audit performed by authorities
Requirements
At least 2 years in Pharma / Healthcare doing Quality /ISO /GMP
University degree in a technical discipline (engineering preferred)
Post-graduate development programs, e.g., quality systems, change management, problem solving tools, project management.
Healthcare manufacturing processes and knowledge preferred.
Excellent interpersonal and presentation skills in order to communicate effectively with customers and senior management.
Location: Jurong Island (100% onsite)
(The company transport picks up at lakeside MRT, morning 7.45am & 7.55am, evening 5.35pm & 5.45pm)
Working hours: 8.30am to 5.30pm (Mondays to Fridays); with 1-hour lunch break.
Salary: $4K to 5.5K max per month + 250 site allowance + 1.5 month completion bonus + 14 days AL + $00 medical + 1000 specialist per year
Interest applicants, pls email updated resume to
Jessie Hoe Huey Miin
CEI Reg No. R
EA Lic: 99C4599
#J-18808-Ljbffr

1. Act as the contact point for local medical gases and medical devices safety issues within normal business hours. If LVO holds the role as local QPPV, LVOs must be reachable 24 hours/day, 7 days/week.
2. Implementing pharmacovigilance (PV) and medical device vigilance according to the local vigilance standard operating procedure which is developed based on the local and global vigilance requirement.
3. Work with OS QRA in maintaining the local Vigilance system.
4. Pharmacovigilance Processes
5. Notifying Global Pharmacovigilance (PV) Management
6. Quality Incident Management
7. Reconciliation and self -assessment
8. Public Adverse Event Reporting
9. Agency Reporting
10. Periodic Safety Update Reports
11. Risk Management Plan
12. Global Vigilance Audit by Global Assessment
13. Third-Party Healthcare Contractors Vigilance Audit
14. Inspection (Audit performed by authorities

Requirement:

• At least 2 years in Pharma / Healthcare doing Quality /ISO /GMP
• University degree in a technical discipline (engineering preferred)
• Post-graduate development programs, e.g., quality systems, change management, problem solving tools, project management.
• Healthcare manufacturing processes and knowledge preferred.
• Excellent interpersonal and presentation skills in order to communicate effectively with customers and senior management.

Location: Jurong Island (100% onsite)

(The company transport picks up at lakeside MRT, morning 7.45am & 7.55am, evening 5.35pm & 5.45pm)

Working hours: 8.30am to 5.30pm (Mondays to Fridays); with 1-hour lunch break.

Salary: $4K to 5.5K max per month + 250 site allowance + 1.5 month completion bonus + 14 days AL + $00 medical + 1000 specialist per year

Interest applicants, pls email updated resume to

Jessie Hoe Huey Miin

CEI Reg No. R

EA Lic: 99C4599