Assistant Manager

1 day ago

Hyderabad, India Aurore Life Sciences Full time

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).

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