Quality Assurance Associate - Drug Product

Responsibilities:

• To Ensure shop floor compliance by involving in Line Clearance activities for Formulation, Filling, Optical Inspections and Packaging Activities.
• To 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. To Support for the Execution of Aseptic Media Fill Simulation activities.
• To Perform periodic verification of GMP records to ensure that data generated and documented at GMP floor are in compliance with ALCOA principle.
• Responsible for ensuring the drug product related Control Samples compliance.
• To ensure and comply the finished product time out of refrigeration and material management with in Production- Packing.
• Review and Approval of MFRs, BOMs, BPRs, SOPs (New, Revised & Executed Batch Records) and Validation protocols related to Formulation, Filling and Packaging Operations.
• Review of drug product MFR/BPR’s for commercial and developmental products manufactured in cGMP facility.
• Review of Change Controls, Incidents, CAPAs.
• To Perform investigation for deviations, and market complaints. To carryout/execute timely line clearance and carry out routine and non- routine spot check on shop floor.
• To Participate External and Internal Audits.
• Compilation of Annual product quality report (APQRs) for commercial drug products.
• Execution of Area, Process and Product change over line clearances for filling and packaging related activities.
• Sampling of Drug Product samples for LRA testing.
• To support for out of specification/out of limit (OOS/OOL) investigations related to product and environments.
• To Perform System / Process, audit trial for manufacturing equipment.
• To support, monitor Transport Validation activities.
• To verify temperature data of export shipments.

Function: Other
Experience Level: Mid-Senior Level