Key Responsibilities

- To prepare and review of URS, DQ, QRM, FAT, SAT, and vendor/ suppliers documents related to qualification.
- To execute Qualification / Re-Qualification and Validation activities of Equipment / System / Facility and Plant utilities (HVAC system, Autoclave, Isolator, Filling machine, Washing machine, Depyrogenation tunnel, UAFs, Packaging equipment, Water system, Pure steam generation and distribution system, Nitrogen/compressed air distribution system etc.).
- To perform qualification activities like air flow visualization study, Temperature mapping of Rooms/Chambers, Packaging validation, Transport validation etc.
- To co-ordinate with manufacturing, Engineering, Material Management, QC personnel and other users for respective Qualification / Validation / Re-qualification activities for timely completion of activities.
- To prepare and review Validation/ Qualification protocols and reports (IOQ, PQ, RQ, CQ, other miscellaneous qualification documents etc).
- To prepare and review process validation, cleaning validation,



media fill and hold time study protocols and reports.
- To prepare and review of SOPs of Validation and Quality Assurance Department.
- To prepare and update Annual Validation Planner.
- To prepare and execute project validation master plan for commissioning and qualification of current/modified facility.
- To assess Change Control, Deviation, CAPA etc. and participate in investigation triggered through deviation, OOS, OOT or other failures.
- To involved in QMS related activities i.e initiation and review of QMS elements.
- To prepare, review and execute risk assessment activity related to equipment/ process/ facility/ system.
- To conduct sampling activities as per the protocols (Hold time, Process validation and cleaning validation etc.).
- Establish, monitor and maintain Validation function for audit readiness.
- To prepare VMP and SMF.

To implement contamination control strategy at site

📌 QA Validation (Ahmedabad)
🏢 Amneal Pharmaceuticals
📍 Ahmedabad