GMP QA Lead: CSV & Manufacturing Systems

Jefferson Wells Belgium; Waals-Brabant; Sur place; EUR 70 000 - 95 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

QA experience

CSV

GMP knowledge

Data integrity

Investigations

Change controls

Cross-functional collaboration

Description du poste

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.