- Preparation, review and approval of URS for all the manufacturing equipment, analysis and comparison of technical offer received from various vendors.

- Responsible for the trouble shooting, ongoing technical process validation, continuous process verification and process improvement.

- Implementation of cGMP and safety at all stages of manufacturing activities.

- Preparation, review of qualification/ validation documents and execution of qualification/ validation activities.

- Preparation, reviewing and approval of the current equipment (FAT & SAT) & equipment Risk Assessments, URS, DQ, FDS, IQ, OQ and PQ documents.

- Reviewing the equipment P&ID;, area Layouts.

- Review and approval of Equipment validation, Process validation, Process simulation documents.

- Coordinate with MS&T; for product transfer and execution of scale up and Registration batches.

- Preparation,



review and approval of process flow diagrams and component specifications as per process requirement.

- Responsible for preparation, review and approval of standard operating Procedure (SOPs), operating instructions, and cleaning Instructions.

- Responsible for the preparation, review and approval of Master Manufacturing Record and Batch Manufacturing Record.

- Organize and co-ordinate training activities, preparation of documents and maintenance of training records. Oversee daily operations during the assigned shift.

- Ensure smooth transition between shifts, maintaining continuous production flow.

- Ensure documentation is up-to-date and compliant with standard operating procedures.

- Audit Compliance

- Handling of regulatory audit

📌 Executive Supervisor - Injectable (Vadodara)
🏢 Alembic Pharmaceuticals
📍 Vadodara