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 QA Officer (GMP Environment)
Builds
Sterile pharmaceutical products (liquids and lyophilized) for clinical and commercial use
Domain
Pharmaceutical manufacturing / Sterile production
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, sterile manufacturing oversight, batch record review, SOP management, cleanroom supervision, audit execution, media fill observation, sterilization validation, AQL visual inspection
Preferred skills
FMS systems knowledge, cleanroom gowning expertise, modification control implementation, re-validation support
Technologies
LIMS, SAP, FMS systems
Responsibilities
Review sterilization cycles and cleanroom controls; manage logbooks and area control compliance; perform online batch record review and close batches; update 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 Operations staff; observe media fills; perform cleanroom physical checks (velocities, air patterns, DOP tests, particle counting); re-qualify autoclave loads and test sterilizing filters; validate cleaning processes; conduct AQL-based visual inspections.
Seniority
Senior, hands-on IC
