Manufacturing System Quality Partner

Jefferson Wells Belgium; Waals-Brabant; On-site; EUR 70,000 - 95,000; Full time

Job summary

Jefferson Wells Belgium is seeking a Manufacturing System Quality Partner - CSV to provide QA oversight for manufacturing systems and related infrastructure. You will support equipment qualification, validation, cleaning validation and environmental monitoring, while driving investigations and quality events as needed.

Regularly interact with stakeholders and occasionally be present in production areas to resolve quality issues in a GMP/compliant environment.

Qualifications

• Solid QA background in a GMP environment.
• Strong experience in Computerized Systems Validation (CSV).
• Knowledge of 21 CFR Part 11 and data integrity principles.
• Experience with equipment qualification and validation activities.
• Ability to lead investigations, deviations and change controls.

Responsibilities

• Provide QA oversight for manufacturing systems and infrastructure.
• Support equipment qualification, validation, and cleaning validation.
• Lead or contribute to investigations, deviations, and quality events.
• Participate in change controls and GMP spot-checks.
• Collaborate with technical and production teams to resolve quality issues.

Skills

QA experience

CSV

GMP knowledge

Data integrity

Investigations

Change controls

Cross-functional collaboration

Job description

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.