QA Specialist – New Product Introduction (NPI)
Biopharma Asia
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Benefits offered by this job
Job summary
Johnson & Johnson Innovative Medicine in Beerse, Belgium, seeks a QA Specialist – New Product Introduction (NPI) to ensure quality and compliance are embedded from the start. You will oversee NPI, product transfers, and implementation projects across Device Assembly and Parenteral Packaging, partnering with Manufacturing, Engineering, Regulatory, and Quality teams.
You will drive risk management, documentation review, and timely QA release for NPI batches, enabling smooth launches and compliant
Qualifications
- Experience in GMP-regulated pharmaceutical environments.
- Strong quality mindset with attention to detail and accuracy.
- Ability to work across cross-functional teams and projects.
- Risk-based decision making in a dynamic setting.
Responsibilities
- Act as QA representative for NPI, transfers, and implementation projects.
- Provide QA oversight for NPI lifecycle and GMP alignment.
- Incorporate quality requirements into project plans and deliverables.
- Review GMP documentation, risk assessments, protocols, and reports.
- Support deviations, CAPAs, and change controls with timely resolutions.
- Assist in audits and inspections, and drive continuous improvement.
Skills
Education
Job description
Johnson & Johnson Innovative Medicine in Beerse, Belgium, seeks a QA Specialist – New Product Introduction (NPI) to ensure quality and compliance are embedded from the start. You will oversee NPI, product transfers, and implementation projects across Device Assembly and Parenteral Packaging, partnering with Manufacturing, Engineering, Regulatory, and Quality teams.
You will drive risk management, documentation review, and timely QA release for NPI batches, enabling smooth launches and compliant
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