QA Supervisor - (Pharmaceutical / API Plant)

Your tasks

• 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, escalate 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.
• 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.

• 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.
• Lead or participate in investigations, assessment, review and follow-up of deviations, incidents, change controls, quality risk assessments and CAPAs related to site operations. 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.

Requirements

• Bachelor’s degree or above in Pharmacy, Pharmaceutical Science, Pharmaceutical Engineering, Chemistry, Biotechnology, Quality Management or a related discipline.
• Minimum 5 years of relevant experience in pharmaceutical QA, manufacturing quality, site quality management and/or validation.
• At least 2 years of supervisory, team leadership or people management experience in 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.
• 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.

How to apply

Veronica Neo Shen Hwa - veronica.neo@manpower.com.sg