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 :
Solid 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 setting.
Robust analytical and problem-solving skills.

📌 Production Officer To Senior Executive Vadodara
🏢 Ami Lifesciences
📍 Vadodara