Ipqa Executive

3 days ago


Puducherry Puducherry, India SHASUNMED LIFE SCIENCES PVT. LTD Full time

**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

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