IPQA - Assistant Manager

Job Title:

Department:

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).