IPQA Executive

Job Summary:

We are seeking a proactive and detail-oriented IPQA professional with 2 to 4 years of hands-on experience in pharmaceutical or biopharma manufacturing. The IPQA Executive will be responsible for ensuring in-process compliance on the shop floor, monitoring production activities, and ensuring adherence to cGMP and quality standards.

Key Responsibilities:

• Perform line clearance before the start of manufacturing, packaging, and batch changeovers.
• Monitor in-process checks during manufacturing and packaging activities (e.g., weight variation, hardness, uniformity, yield reconciliation).
• Review of batch manufacturing records (BMRs) and batch packaging records (BPRs).
• Ensure compliance to approved SOPs, Master Batch Records, and current GMP guidelines during operations.
• Verify and document critical process parameters during production activities.
• Handle and escalate on-the-spot deviations, discrepancies, and non-conformances.
• Ensure appropriate environmental conditions, gowning practices, and material handling in cleanrooms or controlled areas.
• Participate in routine area audits, inspections, and self-inspections.
• Support in investigations related to deviations, OOS, OOT, implementation of CAPAs.
• Ensure proper labelling, status control, and traceability of materials and equipment during operations.
• Coordinate with production, engineering, and warehouse teams to maintain compliance on the shop floor.

Qualifications:

• B.Pharm/B.Tech/M.Sc/M.Tech in Life Sciences, Microbiology, Biotechnology.
• 2 to 4 years of IPQA experience in a regulated pharmaceutical or biopharma manufacturing facility (formulations, sterile/non-sterile, or biologics).

Key Skills:

• Experience in Oncology plant is plus
• Sound knowledge of cGMP, GDP, and IPQA practices
• Familiarity with regulatory guidelines (USFDA, EU-GMP, WHO, etc.)
• Ability to detect quality issues in real-time and act decisively
• Good documentation and communication skills
• Ability to work in shifts and under pressure

Job Type: Full-time

Pay: ₹15,000.00 - ₹20,000.00 per month

Benefits:

• Provident Fund

Ability to commute/relocate:

• Pondicheri, Puducherry: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Pharmaceutical: 2 years (Required)
• Oncology: 2 years (Required)

Work Location: In person