Senior QA Specialist - Hybrid: GMP, CAPA & Inspections
Johnson & Johnson Co.
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Résumé du poste
Johnson & Johnson Innovative Medicine Biologics in Leiden, the Netherlands, seeks an experienced QA Specialist to strengthen GMP compliance and product quality within a dynamic pharmaceutical manufacturing environment. You will join a Quality Assurance team supporting investigations, risk management, and compliance initiatives across the site.
In this role you will guide cross-functional partners, participate in inspections, and help ensure actions are implemented effectively.
Qualifications
- Bachelor's degree with 4–6 years of relevant experience, or Master's with 2–4 years.
- Up-to-date knowledge of GMP regulations and quality systems.
- Experience in Quality Assurance within a regulated pharmaceutical environment.
Responsabilités
- Provide quality guidance on cGMP and related topics for site operations.
- Lead and support site investigations and CAPA implementation within timelines.
- Support regulatory inspection readiness activities (FDA/EMA).
- Review and approve deviation-related change controls.
- Collaborate with site colleagues to ensure compliant project execution.
- Review study protocols and reports to ensure controlled, compliant activities.
Connaissances
Formation
Description du poste
Johnson & Johnson Innovative Medicine Biologics in Leiden, the Netherlands, seeks an experienced QA Specialist to strengthen GMP compliance and product quality within a dynamic pharmaceutical manufacturing environment. You will join a Quality Assurance team supporting investigations, risk management, and compliance initiatives across the site.
In this role you will guide cross-functional partners, participate in inspections, and help ensure actions are implemented effectively.
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