Role & responsibilities

- To perform all the activities outlined in SOP.
- Follow online documentation as per Good Manufacturing Practices (GMP) and Valuable Documentation Practices (GDP).

- Responsible for producing Quality drug Product.
- To maintain personnel hygiene and discipline and area gowning procedure.
- To monitor and keep all equipment/ instruments in validated and calibrated state.

- To follow the written procedures and understood the materials transfer philosophy,
- To maintain the discipline in the department & Co- ordination with cross functional team members.

- Preparation and review of DQ, IQ, OQ and PQ of all the manufacturing equipment.
- Coordinate with MS&T; for product transfer and execution of scale up and registration batches.





- To execute the Autoclave, Manufacturing and filling related activities.
- Preparation of SOPs and other master documents of production.
- To prepare and review trends, URS and QRM documents.

- To participate in production equipment Installation, Commissioning and Qualification activities.
- To conduct FAT and SAT of production equipment.
- To execute Scale-Up, Exhibit, Commercial and Engineering run Batches.

- Responsible to ensure that all equipment and lines are in qualified state.

- Audit Compliance

- Handling of regulatory audit

📌 Executive - Aseptic Area Supervisor (Vadodara)
🏢 Alembic Pharmaceuticals
📍 Vadodara