- Responsible for Quality Function responsibilities pertaining to Validation and IPQA for Parenteral Unit
- Responsible for preparation, review and implementation of Standard Operating Procedures of Quality Assurance department.
- Responsible for review and approval of the master and executed documents (SOPs, BMR, BPR, QRM, Investigations, Planner, Calibration certificates, Trends for Environmental monitoring, WFI, Pure Steam etc.) of cross functional team (CFT) for Parenteral Units.
- Responsible for preparation/ review/ approval of Validation/Qualification Protocols and reports i.e. Process Validation, Equipment Validation, Cleaning Validation, Media fills etc. of Parenteral Units.
- Responsible to ensure that Quality systems are established and followed for combination products in accordance with applicable regulations and standards at Parenteral Unit
- Procedure and tracking and collection of stability sample as per SOP/protocol.
- Responsible for review of executed BMRs and BPRs for batch release and release of batch for regulatory filing/commercial distribution at Parenteral Unit
- Responsible for reject of batch not meeting the batch release criteria




- Responsible for the assessment of Change Control, Deviations, CAPA, Investigation etc.
- Responsible to perform the in-process test at different stages as per batch document/SOP.
- Responsible to review the in-process and finished product COA before batch release.
- Responsible to monitor cGMP compliance at shop floor, to provide line clearance at applicable stages and perform the AQL for semi-finished and finished goods.
- Responsible to provide and fulfil the documents requirement of regulatory affairs department for filing or other requirements.
- Responsible to final release the materials (FP, RM, PM) in LIMS.
- To perform aseptic behavior/practice monitoring of operators (while working inside aseptic process area) during each aseptic batch (GMP batch) as per SOP.
- Responsible to identify training needs and impart training of SOP's and developmental trainings within the department and for other department at Parenteral Unit
- Responsible for handling of market complaints, acknowledgement and investigation with proper implementation of corrective and preventive actions.

📌 Manager / Senior Manager - QA Validation (Ahmedabad)
🏢 Amneal Pharmaceuticals
📍 Ahmedabad