QA Supervisor Pharmaceutical​/API Plant

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.
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.