Quality Assurance Officer – In‑Process QA

About the role

The Quality Assurance Officer will ensure shop‑floor compliance with GMP norms and guarantee on‑time delivery of pharmaceutical products. Reporting to the Senior Manager, Quality Assurance, the role focuses on in‑process quality activities across solid oral, cream and ointment dosage forms.

Key responsibilities

• Review change controls, assign tasks to stakeholders and ensure timely closure.
• Monitor corrective and preventive actions (CAPA) and track their resolution.
• Investigate market complaints and deviations, preparing summary reports for each.
• Perform line clearance, inspect shop‑floor activities and conduct swab/rinse sampling of equipment.
• Execute in‑process checks, assay calculations and batch reconciliation during manufacturing and packing.
• Utilise SAP, DMS, QMS and e‑Logs for transaction recording and audit‑trail review.
• Identify process improvement opportunities and ensure compliance across manufacturing, packing and warehouse areas.

Required profile

• B.Pharm, M.Pharm or M.Sc. with 4‑7 years of relevant pharma experience.
• Hands‑on experience in in‑process quality assurance on the shop floor.
• Familiarity with regulatory requirements of US FDA, EU‑GMP, MHRA and TGA.
• Willingness to work all shifts, weekends and travel to other sites as needed.

Required skills

• SAP
• DMS
• QMS
• e‑Logs
• Assay calculation
• Batch reconciliation
• Swab and rinse sampling
• Audit‑trail and alarm review