Qualified Person (Deputy)
Generics manufacturer, Utrecht region
(Example vacancies. These show how a role is presented; they are not live searches.)
- Utrecht, NL
- Permanent
- €95–115k per year
- Start: Q1 2027
- Ref. BL-1044
Posted
About the role
A generics manufacturer near Utrecht with an oral solid dose licence covering over forty products is appointing a second named QP. You certify batches alongside the current QP, own the self-inspection programme and represent the site during the next IGJ inspection.
Your responsibilities
- Certify batches under Annex 16 for EU release
- Own the self-inspection programme and supplier qualification decisions
- Chair the deviation review board for major and critical events
- Lead regulatory inspection hosting and CAPA follow-up
- Deputise for the Head of Quality
What you bring
Must-haves
- Meets Directive 2001/83 Article 49 QP eligibility (we check before presenting)
- 5+ years QA in solid dose or similar; certification experience preferred
- Dutch B2, the shop floor and the inspectorate work in Dutch
- Demonstrated independence in release decisions
Nice-to-haves
- Prior named Deputy QP status
- Experience with variations and RA interface
- Lead auditor qualification
What's offered
- €95,000–115,000 gross per year plus 10 % bonus
- Company car or mobility budget, pension via the pharma CAO
- Named on the licence within three months
- Clear path to QP and Head of Quality
About the company
A Dutch-owned generics manufacturer with around 250 staff, supplying hospital and retail pharmacy across the Benelux and Nordics.
How we screen this role
Eligibility check first, then a certification-judgement conversation with the founder: a batch with an open major deviation, and what you would rely on to certify it.
Apply for this role
Qualified Person (Deputy) · BL-1044
Qualified Person (Deputy)
€95–115k