Site QA Supervisor (Pharmaceutical / GMP)

Manpower Singapore; Singapore; On-site; SGD 120,000 - 180,000; Full time

Benefits offered by this job

Medical coverage

Career growth opportunities

Job summary

Manpower Singapore is seeking a Site Quality Manager to lead QA activities across manufacturing, packaging, warehouse and supporting areas to ensure GMP, QMS and regulatory readiness.

You will supervise QA personnel, develop site QA plans, oversee material release and cleaning validation, and lead audits and CAPA processes with a strong focus on data integrity and continuous improvement.

Qualifications

• Bachelor’s degree or above in Pharmacy, Pharmaceutical Science, or a related discipline.
• Minimum 5 years of relevant experience in pharmaceutical QA, GMP, and site quality management.
• At least 2 years of supervisory or teams leadership experience in QA.
• Knowledge of GMP standards (PIC/S, EU, FDA) and data integrity practices.

Responsibilities

• Lead on-site QA activities to ensure GMP, QMS and regulatory compliance.
• Develop site QA work plans and allocate resources for monitoring and material release.
• Supervise QA personnel and provide coaching for effective quality oversight.
• Conduct GMP inspections, audits, and quality risk assessments; drive issue resolution.
• Provide QA oversight during cleaning validation, deviation management and CAPA tracking.

Skills

GMP knowledge

QA leadership

Documentation control

Root cause analysis

Data integrity

Audit coordination

Education

Bachelor’s degree in Pharmacy or related field

Tools

LIMS

SAP

Job description

1. Site Quality Management

• Lead and manage on-site quality assurance activities in manufacturing, packaging, warehouse and supporting areas to ensure compliance with GMP, the Quality Management System (QMS), and applicable regulatory requirements.
• Develop Site QA work plans and allocate resources for routine shop-floor monitoring, GMP walkthroughs, documentation review and material release activities.
• Supervise, coach and develop Site QA personnel to ensure consistent and effective execution of assigned quality oversight activities.
• Conduct routine GMP inspections, focused audits, internal self-inspections and quality risk assessments; identify, escalation and drive timely resolution of quality and compliance issues.
• Provide real-time QA oversight of critical manufacturing activities, process controls, line clearance, material status labeling, personnel practices, housekeeping, documentation practices and data integrity.

2. Material Release

• Review and approve documentation supporting the release of raw materials and packaging materials for use, ensuring compliance with approved supplier status, testing status, storage requirements, labeling and applicable specifications.
• Oversee Site QA activities related to material release, material status control and disposition of non-conforming or abnormal materials.
• Review master cleaning records, line clearance records, SOPs and related controlled documents to ensure GMP compliance and alignment with actual site practices.

3. Cleaning Validation System

• Establish, maintain and continuously improve the site cleaning validation program and associated quality system.
• Develop, review and approve cleaning validation policies, SOPs, validation plans, protocols, reports and related technical documentation.
• Lead or coordinate cleaning validation risk assessments, including equipment and product grouping, worst-case product selection, residue limit establishment, sampling strategies, analytical methods, acceptance criteria and revalidation requirements.
• Review and approve cleaning validation protocols, cleaning validation reports, cleaning verification reports and periodic review reports.
• Provide QA oversight during cleaning validation execution
• Review cleaning-related deviations, changes, CAPAs and impact assessments, and assess potential impact on product quality, cross-contamination control and validation status.
• Conduct periodic review of cleaning procedures and validation status, identify revalidation needs, and implement continuous improvements to cleaning processes and cross-contamination control measures.

4. Deviation, Change Control and CAPA Management

• Lead or participate in investigations, assessment, review and follow-up of deviations, incidents, change controls, quality risk assessments and CAPAs related to site operations.
• Lead cross-functional investigations for critical, recurring or systemic quality issues and ensure robust root cause analysis is performed.
• Ensure corrective and preventive actions are implemented within agreed timelines and verify their effectiveness.
• Perform periodic trend analysis of deviations, audit findings, cleaning-related issues and other site quality metrics to identify improvement opportunities.

5. Customer Audit and Regulatory Inspection Management

• Lead Site QA preparation, coordination and support for customer audits, regulatory inspections, third-party audits and internal audits.
• Act as the primary Site QA contact for matters related to shop-floor quality management, material release, cleaning management and cleaning validation during audits and inspections.
• Coordinate the preparation and review of audit documentation, including material release records, cleaning and line clearance documentation, cleaning validation documents, deviations, change controls and CAPA evidence.

• Bachelor’s degree or above in Pharmacy, Pharmaceutical Science, Pharmaceutical Engineering, Chemistry, Biotechnology, Quality Management or a related discipline.
• Minimum5 years of relevant experiencein pharmaceutical QA, manufacturing quality, site quality management and/or validation.
• At least 2 years of supervisory, team leadership or people management experiencein a Site QA, Quality or related function.
• Knowledge of Singapore HSA GMP requirements and international GMP standards. Experience with PIC/S GMP, EU GMP, FDA cGMP and/or WHO GMP
• Demonstrated experience in establishing, maintaining and executing a cleaning validation system.
• Sound knowledge of cleaning validation lifecycle management, quality risk assessment, worst-case selection, residue limit setting, sampling and analytical strategies, acceptance criteria, validation protocols and report review.