Quality Assurance Associate - Drug Product
Core
Ensure shop floor compliance and monitor GMP adherence for Formulation, Filling, Optical Inspections, and Packaging Activities in a biosimilar manufacturing facility.
Role type
Quality Assurance Associate (Drug Product)
Builds
Commercial and developmental biosimilar drug products
Domain
Pharmaceutical manufacturing (Biosimilars)
Required skills
GMP compliance, Line Clearance, Aseptic Media Fill Simulation, ALCOA principle verification, Change Control review, Deviation investigation, CAPA execution, Audit participation, APQR compilation, OOS/OOL investigation, Equipment audit, Transport validation, Temperature data verification
Preferred skills
Experience in Injectable products, Knowledge of cGMP facilities
Technologies
Manufacturing execution systems, GMP record systems, Validation protocols
Responsibilities
Ensure shop floor compliance by involving in Line Clearance activities for Formulation, Filling, Optical Inspections and Packaging Activities; Monitor and ensure that all activities involved in Formulation, Filling, Optical Inspections and Packaging Activities are in compliance with GMP and Standard operating procedures; Review of Aseptic Media Fill Simulation Protocols and Reports; Perform periodic verification of GMP records to ensure that data generated and documented at GMP floor are in compliance with ALCOA principle; Review and Approval of MFRs, BOMs, BPRs, SOPs and Validation protocols related to Formulation, Filling and Packaging Operations; Perform investigation for deviations, and market complaints; Participate External and Internal Audits; Compilation of Annual product quality report (APQRs) for commercial drug products; Sampling of Drug Product samples for LRA testing; Support for out of specification/out of limit (OOS/OOL) investigations related to product and environments; Perform System / Process, audit trial for manufacturing equipment; Support, monitor Transport Validation activities; Verify temperature data of export shipments.
Seniority
Mid-Senior level (8-10 years experience)
