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Assistant Manager
2 weeks ago
Job Title: Assistant Manager In-Process Quality Assurance (IPQA)
Department: Quality Assurance
Location: Hyderabad, Jeedimetla
Reporting To: Manager Quality Assurance / Head Quality
Job Purpose:
To ensure that all in-process operations are monitored and compliant with applicable cGMP, SOPs, and regulatory requirements. The IPQA Assistant Manager is responsible for in-line quality checks, deviation control, batch record review, and timely escalation of non-conformities during manufacturing and packaging processes.
1. In-Process Quality Monitoring
- Supervise and execute IPQA activities during manufacturing and packaging.
- Perform real-time line clearance, process checks, and verification.
- Ensure compliance with Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR).
2. Documentation and Compliance
- Review in-process documents for accuracy and completeness.
- Ensure that manufacturing and packaging operations are performed as per SOPs and GMP guidelines.
- Maintain and archive IPQA records in a compliant manner.
3. Deviation & Change Control
- Identify, report, and investigate deviations, non-conformities, and incidents.
- Assist in the implementation of CAPA (Corrective and Preventive Actions).
- Coordinate with production, quality control, and other departments to resolve quality issues.
4. Audits & Regulatory Compliance
- Assist during internal, external, and regulatory audits (e.g., USFDA, MHRA, WHO).
- Ensure readiness of IPQA documentation and process compliance.
- Implement audit recommendations in coordination with QA leadership.
5. Training & Team Management
- Train IPQA staff and production teams on quality systems, SOPs, and GMP.
- Supervise IPQA officers/inspectors and ensure their optimal performance.
- Promote a culture of quality and continuous improvement on the shop floor.
Key Skills and Competencies:
- Strong knowledge of cGMP, GDP, and regulatory standards (USFDA, MHRA, WHO-GMP, etc.)
- Excellent documentation and communication skills.
- Experience with QMS tools (e.g., deviation, change control, CAPA systems).
- Ability to lead and coordinate cross-functional teams.
Qualifications:
- B.Pharm / M.Pharm / B.Sc / M.Sc in Chemistry, Microbiology, or related discipline.
Experience:
- Minimum 6-10 years of relevant experience in IPQA, preferably in pharmaceutical manufacturing (API).
