Manufacturing System Quality Partner

Manufacturing System Quality Partner - CSV

Brabant Wallon - Contracting

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.

🧩 Responsibilities:

• 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.

📅 Requirements:

• 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.
• Fluent in English.
• 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.
• French language skills.