Manufacturing System Quality Partner
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Manufacturing System Quality Partner - CSV
The position focuses on providing QA oversight for manufacturing systems, equipment qualification, cleaning validation, environmental monitoring, quality investigations, compliance activities, and increasingly complex computerized systems.
- Act as the QA partner for manufacturing systems and infrastructure supporting biologics production.
- Activities may include supporting equipment qualification and validation, reviewing and assessing computerized systems, leading or contributing to investigations, deviations and quality events.
- Participating in change controls, performing compliance tours and GMP spot-checks.
- Collaborating with technical and production teams to resolve quality issues, and ensuring compliance with GMP and data integrity requirements.
- The role requires regular interaction with multiple stakeholders and occasional presence in production areas when quality issues arise.
- Minimum 5 years of relevant experience required.
- Strong experience in QA within a GMP-regulated pharmaceutical or biologics environment.
- Previous exposure to manufacturing systems, qualification/validation activities and computerized systems is expected.
Must have:
- Solid QA background in a GMP environment.
- Strong experience in Computerized Systems Validation (CSV) and computerized manufacturing systems.
- Knowledge of 21 CFR Part 11, data integrity principles and computerized quality systems.
- Experience with equipment qualification and validation activities.
- Understanding of investigations, deviations, change controls and compliance processes.
- Ability to critically assess validation documentation and quality risks.
- Good understanding of regulatory requirements and GMP expectations.
- Strong communication skills and ability to work cross-functionally with multiple stakeholders.
- Ability to work autonomously and manage complex situations with limited supervision.
Nice to have:
- Experience within biologics manufacturing.
- Experience in drug substance manufacturing, facility operations or laboratory compliance.
- Knowledge of water systems, cleaning validation, environmental monitoring or manufacturing infrastructure.
- Technical IT background allowing deeper understanding of computerized systems and investigations.
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