Roles and Responsibilities :

- Design, develop, and optimize batch manufacturing processes for pharmaceutical products in accordance with cGMP guidelines.
- Conduct cleaning validation, sterilization (autoclave), and equipment qualification activities to ensure compliance with regulatory requirements.
- Investigate deviations and implement corrective actions to prevent recurrence of issues affecting product quality or regulatory compliance.
- Collaborate with cross-functional teams to resolve production problems and improve overall efficiency.
- Documentation experience for CAPA< Change control, Deviation report and Sop change.

Job Requirements :

- 1-8 years of experience in aseptic processing, batch manufacturing, BMR review, change control, clean room design/operation/maintenance.
- Robust understanding of injectables/injection molding principles and vial washing procedures.
- Familiarity with GMP regulations (e.g., FDA) and industry standards (e.g., ISO).

📌 Process Engineer (Valsad)
🏢 Schott Poonawalla
📍 Valsad