Roles and Responsibilities :

- Develop, implement, and maintain batch manufacturing processes for injectable products in accordance with cGMP guidelines.

- Ensure compliance with regulatory requirements by implementing change controls, deviation management, and cleaning validation procedures.

- Collaborate with cross-functional teams to resolve issues related to product quality, production scheduling, and equipment maintenance.

- Conduct audits and inspections of facilities, equipment, and documentation to ensure adherence to regulatory standards.

- Documentation of CAPA, Change control and Deviation Reports.

Job Requirements :

- 1-8 years of experience in pharmaceutical industry with expertise in batch manufacturing (BMR) or similar field.

- Robust understanding of aseptic technique, autoclave operation, vial washing procedures, and sterile processing principles.

- Experience with document control systems such as BMRS (Batch Manufacturing Records System).

- Familiarity with GMP regulations including FDA guidelines on Good Manufacturing Practices.

📌 Process Engineer (Killa-pardi)
🏢 Schott Poonawalla
📍 Killa-pardi