CAR-T Quality Reviewer & CAPA Coach

Johnson & Johnson; Gent; Sur place; EUR 83 000 - 131 000; Plein temps

Résumé du poste

Johnson & Johnson Innovative Medicine in Belgium seeks a QS Reviewer to independently review nonconformities and CAPAs for CAR-T BE operations across Obelisc Ghent, Tech Lane Ghent, QC Beerse and cCPC Beerse. You will coach investigation teams on how to assess and document quality investigations in line with procedural requirements.

The role requires a Master Scientific degree, strong knowledge of cGMP and ICH guidelines, 5+ years in Quality Systems, fluent English, and experience coaching

Qualifications

• Master level degree with a technical specialization in analytics, chemistry, biotechnology, pharmaceutical sciences or engineering.
• Strong knowledge of cGMP, ICH guidelines, policies, standards and procedures.
• Min. 5 years of experience in Quality Systems or Quality Assurance related to manufacturing.
• Good knowledge of cGMP regulations related to sterile manufacturing.
• Solid understanding of Quality Systems processes, specifically nonconformity and CAPA handling.
• Fluent knowledge of English.
• Experience coaching personnel on investigation practices.
• Familiarity with systems such as COMET, Truvault, SUMMIT and MS Office.

Responsabilités

• As part of the Quality Systems team, you will drive compliance and high-quality standards across CAR-T operations.
• This will involve:
• Review nonconformity risk assessments and CAPA end-to-end investigations according to the requirements stipulated in global and local procedural documents.
• Collaborate with investigation teams and Quality members to ensure risk assessments and investigations are conducted and documented in a proper manner.
• Coach personnel involved in the Nonconformity and CAPA handling process on good investigational practices.
• Collaborate with Quality Systems team members and process stakeholders to ensure reviews are conducted in a timely manner.
• Perform tasks in a manner consistent with safety policies, quality systems, and cGMP requirements.
• Monitor compliance with legal requirements together with the SHE department and actively contribute to safety and environmental prevention.

Connaissances

Analytical thinking

Structured communication

Coaching mindset

Fluent English

cGMP knowledge

Investigation coaching

Quality Systems familiarity

Formation

Master's degree in analytics/chemistry/biotechnology/pharmaceutical sciences/engineering

Outils

COMET

Truvault

SUMMIT

MS Office

Description du poste

Johnson & Johnson Innovative Medicine in Belgium seeks a QS Reviewer to independently review nonconformities and CAPAs for CAR-T BE operations across Obelisc Ghent, Tech Lane Ghent, QC Beerse and cCPC Beerse. You will coach investigation teams on how to assess and document quality investigations in line with procedural requirements.

The role requires a Master Scientific degree, strong knowledge of cGMP and ICH guidelines, 5+ years in Quality Systems, fluent English, and experience coaching