Sr Officer - Quality Assurance

About the role

The Senior Officer – Quality Assurance will oversee in‑process quality assurance (IPQA) activities on the manufacturing and packaging lines, ensuring compliance with current Good Manufacturing Practices (cGMP) and US FDA regulations. The role requires close interaction with production teams to maintain product quality and regulatory standards throughout the batch lifecycle.

Key responsibilities

• Perform line clearance before batch start‑up or change‑over.
• Monitor critical manufacturing steps such as dispensing, granulation, compression, coating, and packing.
• Verify adherence to Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR) instructions on the shop floor.
• Conduct in‑process quality checks (IPQC) including weight variation, hardness, friability, and other relevant tests.
• Ensure proper status labeling, cleanliness, and material identification.
• Check real‑time documentation for Good Documentation Practice (GDP) compliance.
• Report deviations or abnormalities observed during operations.
• Confirm use of approved materials, equipment, and standard operating procedures.
• Coordinate with production to ensure smooth and compliant execution of activities.

Required profile

• Bachelor’s or Master’s degree in Pharmacy (B.Pharm / M.Pharm).
• 0–3 years of experience in IPQA, preferably in oral solid dosage (OSD) manufacturing.

Required skills

• Basic knowledge of cGMP guidelines.