Senior QA Engineer - Equipment Qualification (Pharma GMP)

Johnson Johnson; Geel; Sur place; EUR 70 000 - 90 000; Plein temps

Avantages offerts par ce poste

Meal vouchers

Additional pension plan

Hospitalisation insurance

Résumé du poste

Johnson & Johnson is seeking a Staff Quality Engineer in Geel, Belgium, to oversee production equipment quality in the Innovative Medicine Supply Chain. You will drive qualification activities, ensure cGMP compliance, and collaborate with engineering and operations to implement robust QA processes.

The role emphasizes regulatory audits, cross-functional teamwork, and continuous improvement to ensure reliable supplies of SM-APIs and DP Intermediates at the Geel site.

Qualifications

• Master's degree in a scientific field or equivalent experience.
• 4–6 years' experience in pharmaceutical or chemical industry.
• Knowledge of cGMP/Qualification compliance (21 CFR Part 211; EU Directive 2003/94/EC and annex 11/15).

Responsabilités

• Ensure that all Equipment Qualification related regulatory requirements are fulfilled during the complete life cycle (concept, project, operational and retirement phase).
• Review and approve Qualification documents such as SOPs, user requirements, risks analyses, Qualification Plans, tests, changes, deviations etc. to maintain compliance to regulations and J&J standards.
• Maintain knowledge of international laws and guidelines related to Qualification; apply learnings to improve Equipment Qualification at J&J.
• Prepare for audits and inspections; represent in audits.
• Perform and follow up on internal and external audits to achieve regulatory compliance.
• Cooperate with engineering, operations and other teams for introduction of new systems and processes.
• Provide advice and support for Qualification activities; ensure cGMP in new projects; participate in multi-functional teams.
• Ensure that Innovation projects are designed and implemented within the GMP Quality framework, handling quality records such as Change Controls, Investigations and CAPAs.

Formation

Master's degree in a scientific field

Description du poste

Johnson & Johnson is seeking a Staff Quality Engineer in Geel, Belgium, to oversee production equipment quality in the Innovative Medicine Supply Chain. You will drive qualification activities, ensure cGMP compliance, and collaborate with engineering and operations to implement robust QA processes.

The role emphasizes regulatory audits, cross-functional teamwork, and continuous improvement to ensure reliable supplies of SM-APIs and DP Intermediates at the Geel site.