QA Engineering Manager – Lab & CSV Systems

Johnson & Johnson Innovative Medicine; Geel; Sur place; EUR 80 000 - 138 000; Plein temps

Avantages offerts par ce poste

Meal vouchers

Pension plan

Hospitalization insurance

Résumé du poste

Johnson & Johnson Innovative Medicine in Geel, Belgium is seeking a Manager Quality Engineering – Lab and Computerized System Validation to lead the QA Qualification and CSV activities for Lab, Automation and IT systems used in manufacturing APIs and DP Intermediates.

You will head a sub-team, manage resources and budgets, drive compliance with cGMP and support regulatory inspections, while pushing continuous improvement and staff development in a fast-paced, collaborative environment.

Qualifications

• Master scientific degree or equivalent experience.
• 5-10 years’ experience in Chemical and/or Pharmaceutical Quality.
• Fluent in Dutch and English (written and spoken).
• Thorough knowledge of cGMP regulations and guidelines for qualification/CSV.
• Knowledge of GMP systems landscape: Lab systems and IT & Automation Systems.
• Strong analytical thinking, risk assessment, communication and leadership skills.

Responsabilités

• Maintain qualification/CSV status for Lab, Automation and IT systems throughout their life cycle.
• Review/approve qualification/CSV docs and related quality reports.
• Participate in system change projects ensuring quality and compliance.
• Prepare for regulatory inspections and support audits as QA spokesperson.
• Drive improvements and corrective actions for qualification/CSV processes.
• Maintain knowledge of international regulations and industry practices.

Connaissances

Fluent in Dutch

Fluent in English

Leadership

Quality engineering

Risk assessment

Formation

Master's degree in Science/Engineering

Outils

GMP systems

Lab systems

IT & Automation Systems

Description du poste

Johnson & Johnson Innovative Medicine in Geel, Belgium is seeking a Manager Quality Engineering – Lab and Computerized System Validation to lead the QA Qualification and CSV activities for Lab, Automation and IT systems used in manufacturing APIs and DP Intermediates.

You will head a sub-team, manage resources and budgets, drive compliance with cGMP and support regulatory inspections, while pushing continuous improvement and staff development in a fast-paced, collaborative environment.