Quality Assurance

2 days ago

Ahmedabad, Gujarat, India Upman Placements Full time US$ 80,000 - US$ 1,20,000 per year

Job Description QA-Qualification –Injectable /Parenteral – (Officer/Senior Officer/ Executive)

Job Location – Sanand, Ahmedabad (Injectable Facility)

No of Position - 03

Total Experience - 2-7 Years in Injectable Manufacturing

Education –B. Pharmacy/M. Pharmacy

Will appreciate immediate joiner for this role

Oversight and Governance

  • QA ensures that all qualification activities (DQ, IQ, OQ, PQ) follow Good Manufacturing Practices (GMP) and regulatory guidelines (e.g., US FDA, EU GMP, WHO).
  • Participates in project planning for qualification activities.
  • Reviews and approves Qualification Master Plan (QMP).

Document Review and Approval:

QA is responsible for reviewing and approving all qualification documentation:

  • Design Qualification (DQ):
  • Ensures the design of equipment/facility meets regulatory and user requirements.
  • Installation Qualification (IQ):
  • Verifies that equipment and systems are installed as per specifications.
  • Operational Qualification (OQ):
  • Ensures equipment operates within defined parameters.
  • Performance Qualification (PQ):
  • Confirms equipment consistently performs under routine conditions using real products or simulations.

Change Control and Deviation Management

  • Evaluates and approves change controls related to equipment or facility qualification.
  • Investigates and approves resolution for deviations arising during qualification.
  • Ensures CAPA (Corrective and Preventive Actions) are effective and documented.

Material and Component Qualification : Ensures that raw materials, primary packaging materials (vials, stoppers, syringes), and excipients are qualified and sourced from approved suppliers.

Environmental and Utility Qualification

Oversees the qualification of:

  • HVAC systems
  • Cleanrooms (classified areas)
  • Water systems (WFI, PW)
  • Compressed gases
  • Ensures compliance with microbiological and particulate limits.

Sterility Assurance

QA is heavily involved in qualifying systems that ensure sterility:

  • Sterilizers (autoclaves, dry heat ovens)
  • Aseptic filling lines
  • Depyrogenation tunnels
  • Isolators and RABS

Data Integrity and Traceability

  • Ensures that qualification activities are well documented.
  • Verifies compliance with data integrity standards (e.g., ALCOA+ principles).
  • Ensures audit trails for electronic systems.

Requalification and Periodic Review

  • QA defines and approves the requalification frequency.
  • Monitors ongoing performance trends to determine if requalification is needed.

Final Release/Approval

  • QA provides the final sign-off for qualified systems or equipment before they are released for GMP use.
  • Ensures all required documentation is complete, accurate, and archived.

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