Quality Engineering Manager — Facilities & Equipment

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

Avantages offerts par ce poste

Meal vouchers

Additional pension plan

Hospitalization insurance

Résumé du poste

Johnson & Johnson Innovative Medicine in Geel, Belgium, seeks a Manager Quality Engineering to lead QA qualification for facilities, utilities and production equipment used in API/DP intermediates. You will guide qualification activities, manage budget, and drive continuous improvement within a dynamic QA team.

You will oversee qualification documentation, calibration and change controls, ensuring regulatory compliance and readiness for inspections while fostering collaboration and technical

Qualifications

• Master scientific degree or equivalent experience.
• 5-10 years’ experience in Chemical and/or Pharmaceutical Supply Chain and/or Quality.
• Thorough knowledge of cGMP regulations and guidelines in the area of qualification.
• Knowledge of the different systems used during the manufacturing process
• Strong analytical thinking, risk assessment, communication, managerial and leadership skills.
• Collaboration and teaming skills.
• Mindset for innovation and optimization
• Fluent in Dutch and English (written and spoken).

Responsabilités

• QA Qualification Operational activities: Assuring that the qualification status is maintained during the life cycle of the systems in scope.
• Review and approval of qualification documents, Periodic System Quality Reviews, Validation Master Plans, Periodic Trend reports, calibration procedures and records, maintenance procedures and records.
• Participate in system introduction and system change projects and assure quality and compliance aspects.
• Prepare for regulatory and customer inspections and act as a spokesperson for QA qualification related matters during audits.
• Ensuring that deviations related to systems (qualification, maintenance, calibration and/or use) with possible impact on quality and/or compliance are evaluated, thoroughly investigated and that adequate corrective and preventive actions are implemented.
• Pro-actively and continuously challenge the quality of the qualification processes to improve the performance of qualification and develop and implement improvements.
• Maintain a current knowledge of international regulations, guidelines and industry practices related to system qualification.

Connaissances

Quality Management

GMP

QMS

Regulatory

Leadership

Formation

Master's degree or equivalent experience

Description du poste

Johnson & Johnson Innovative Medicine in Geel, Belgium, seeks a Manager Quality Engineering to lead QA qualification for facilities, utilities and production equipment used in API/DP intermediates. You will guide qualification activities, manage budget, and drive continuous improvement within a dynamic QA team.

You will oversee qualification documentation, calibration and change controls, ensuring regulatory compliance and readiness for inspections while fostering collaboration and technical