Qualified Person (QP)
Utrecht, Netherlands · Senior · Permanent
- Posted
- Posted today
- Seniority
- Senior
- Contract
- Permanent
- Working
- Hybrid
- Language
- Dutch preferred
- Salary
- €95k–€120k per year
- QP eligibility
- Required
- Sector
- Consultancy / advisory
- Framework
- EU GMP · GDP
This is an example, not a real vacancy
Nobody is hiring for this role and there is no application to make. It exists so an employer can see how a listing appears before sending one — written as a realistic advert because it doubles as the template we ask for.
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A Qualified Person to take batch certification responsibility for a sterile manufacturing site in the Randstad, working alongside an existing QP and a quality team of eleven.
This is a decision-making role, not an administrative one. You will hold the certification decision, and you will be expected to defend it — to the site leadership when a batch is held, and to the inspector when they ask why it was released.
The site runs aseptic filling under EU GMP with an Annex 1 contamination control strategy that was rewritten last year. The QP has full access to the quality system and reports to the Site Quality Director.
Responsibilities
- Certify batches for release to the EU market under Annex 16, and document the basis of each decision.
- Review deviations, out-of-specification results and change controls affecting product disposition.
- Hold the line on release when the evidence is not there, including when the batch is commercially urgent.
- Act as QP contact during regulatory inspections and support inspection readiness between them.
- Maintain oversight of contract manufacturers and the technical agreements governing them.
Requirements
- Eligible to act as a Qualified Person under Directive 2001/83/EC, and named or nameable on a Dutch manufacturing authorisation.
- At least three years of certification experience, ideally including sterile product.
- Working knowledge of Annex 1 and Annex 16 as applied, not only as read.
- Dutch is an advantage on site; English is the working language of the quality system.
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Salary range
€95k–€120k here. The single biggest driver of whether a candidate opens a listing, and the field most often withheld.
Language requirement
Stated plainly as Dutch preferred. In the Dutch and Belgian market this decides whether someone applies at all.
Contract & seniority
Senior, permanent, hybrid. Vague seniority is the fastest way to attract the wrong applications.
GMP specialisms
QP, batch release, QMS and inspection readiness — which is what puts the role in front of the right people and links it to the knowledge base.
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