QA-Qualification -Injectable / Parenteral-Ahmedabad

Job Location Sanand, Ahmedabad (Injectable Facility)

No of Position - 03

Total Experience

Education

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 :

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.

Interested candidates are can apply on Darpana: 9978604075 OR can email me on darpana@upman.in