NPI QA Specialist - GMP & Launch Readiness
Johnson & Johnson Co.
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Benefits offered by this job
Job summary
Johnson & Johnson Innovative Medicine Beerse site seeks a QA Specialist – New Product Introduction (NPI) to provide Quality Assurance oversight for NPI projects, transfers, and implementation activities. You will collaborate with Manufacturing, Engineering, Validation, Regulatory, and Quality teams to ensure GMP-compliant product launches.
The role emphasizes risk management, change controls, and timely QA release of NPI batches to support market supply and readiness.
Qualifications
- University degree in Pharmaceutical Sciences or related field.
- Minimum 2–5 years of experience in pharma manufacturing/quality.
- Knowledge of GMP, ICH guidelines, and regulatory requirements.
- Fluent Dutch and English, written and spoken.
Responsibilities
- Act as QA representative for New Product Introductions and transfers.
- Provide QA oversight for NPI lifecycle and GMP compliance.
- Ensure quality requirements are integrated into early project plans.
- Advise on design, development, and changes to manufacturing/packaging processes.
- Review and approve GMP documents and risk assessments.
- Support inspections, audits, and continuous improvement initiatives.
Skills
Education
Job description
Johnson & Johnson Innovative Medicine Beerse site seeks a QA Specialist – New Product Introduction (NPI) to provide Quality Assurance oversight for NPI projects, transfers, and implementation activities. You will collaborate with Manufacturing, Engineering, Validation, Regulatory, and Quality teams to ensure GMP-compliant product launches.
The role emphasizes risk management, change controls, and timely QA release of NPI batches to support market supply and readiness.
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