CQA - Sterility, USFDA, Validation & Qualification

You are looking for a person who can act as the Sterility Assurance SME for multiple pharma sterile manufacturing plants.

In simple terms, this person should:

Understand sterile manufacturing operations end-to-end.

Have strong experience in Sterility Assurance.

Be strong in validation and qualification — equipment, processes, facilities, utilities, etc.

Develop/review corporate SOPs, standards and guidelines for sterile plants.

Conduct gap assessments against regulatory/corporate requirements.

Handle and review deviations, investigations, CAPA and change controls related to sterility.

Support sites during USFDA/MHRA/EMA/other regulatory inspections.

Review media fills, aseptic process simulations, environmental monitoring, contamination control strategy, sterilization/depyrogenation, etc.

Work on new sterile facility projects, CQV and qualification/validation.

Review whether CAPAs are actually effective.

Coach site SMEs and transfer best practices across multiple sterile sites.

The key point

Don't look for a normal QA Manager.

The ideal candidate is closer to:

Corporate Sterility Assurance + Sterile Operations + Validation/Qualification + Pharma Manufacturing

And preferably someone who has supported multiple sterile manufacturing sites.