Roles and Responsibilities :

- Oversee API production and bulk drug manufacturing to ensure compliance with regulatory standards.

- Manage batch start-up activities, monitor progress, and calibrate balances for accurate measurements.

- Review technical documents such as batch records, SOPs, BMRs, and validation protocols.

- Ensure knowledge and adherence to cGMP guidelines.

- Coordinate with cross-functional teams to meet production targets efficiently.

- Implement quality control measures to maintain high product quality standards.

Job Requirements :

- Strong understanding of BMR/BPR review processes and regulatory requirements (cGMP/GMP).

- Experience in managing inventory levels using SAP or similar systems.

- Knowledge of batch manufacturing processes for API and bulk drugs.

- Familiarity with CGMP guidelines and regulations.

- Ability to work independently and collaboratively within a team environment.

- Robust analytical and problem-solving skills.

📌 Production | Officer To Senior Executive (Vadodara)
🏢 Ami Lifesciences
📍 Vadodara