Job Description

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 (Current, 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.

📌 Quality Assurance Associate - Drug Product (Hyderabad)
🏢 Dr. Reddy's Laboratories
📍 Hyderabad