Job Purpose

To ensure compliance with cGMP and regulatory requirements during manufacturing, packing, and in-process activities, by effective implementation of IPQA systems, documentation review, and continuous monitoring of shop-floor operations.

Key Responsibilities

1. In-Process Quality Assurance
- Ensure line clearance before start, during changeover, and after completion of manufacturing/packing activities
- Monitor critical process parameters (CPPs) and critical quality attributes (CQAs)
- Verify adherence to BMR/BPR during execution
- Ensure proper status labeling and material movement control

2. GMP Compliance
- Ensure compliance with WHO-GMP / Schedule M / USFDA / EU-GMP as applicable
- Conduct regular shop-floor GMP audits
- Identify deviations, non-conformances, and initiate corrective actions

3. Documentation & Review
- Review and approve:
- Batch Manufacturing Records (BMR)
- Batch Packing Records (BPR)
- Logbooks and in-process records
- Ensure timely closure of deviations, incidents, and OOS/OOT
- Review change controls related to manufacturing and packing

4.



Deviations, CAPA & Investigations
- Initiate and investigate deviations, incidents, and market complaints
- Prepare and implement CAPA with defined timelines
- Track effectiveness of CAPA

5. Validation & Qualification Support
- Support process validation, cleaning validation, and equipment qualification
- Review validation protocols and reports from IPQA perspective

6. Training & Team Management
- Train IPQA officers/executives on:
- GMP practices
- SOPs
- Regulatory expectations
- Allocate duties and monitor team performance

7. Regulatory & Audit Support
- Support internal audits, customer audits, and regulatory inspections
- Prepare and review responses to audit observations related to IPQA

8. SOP Management
- Prepare, review, and implement SOPs related to IPQA activities
- Ensure SOP compliance on the shop floor

Authority
- To stop manufacturing/packing activity in case of critical

📌 Ipqa Officer (Vadodara)
🏢 Elysium Pharmaceuticals
📍 Vadodara