QA Officer (GMP Environment)
Core
Provide quality assurance oversight for sterile pharmaceutical manufacturing operations, ensuring compliance with GMP standards and supporting the production of vaccines and life-saving therapies.
Role type
Senior IC Quality Assurance Officer (GMP Environment)
Builds
Sterile pharmaceutical products (liquids and lyophilized) for clinical and commercial use
Domain
Pharmaceutical manufacturing / Sterile production / GMP compliance
Required skills
GMP compliance, sterile manufacturing operations, cleanroom controls, batch record review, SOP management, audit execution, media fill observation, autoclave validation, particle counting, AQL visual inspection
Preferred skills
FMS systems knowledge, cleanroom gowning procedures, modification controls, re-validation activities
Technologies
LIMS, SAP, FMS systems
Responsibilities
Review sterilization cycles and cleanroom controls; manage logbooks and support area control compliance; perform online batch record review and close batches; review and maintain SOPs; supervise clean rooms and support zones; direct packaging operations; generate and assess minor DRs & CAPAs; implement modification controls; conduct local area and system audits; train and mentor staff; observe media fills; perform cleanroom physical checks; re-qualify autoclave loads; validate cleaning processes; conduct AQL-based visual inspections.
Seniority
Senior, hands-on IC