In European pharmaceutical manufacturing, no batch of medicine reaches the market without one specific signature: that of the Qualified Person. It is a role defined in law, carries personal liability, and sits at the very end of the production chain as the last checkpoint before release.
What does a Qualified Person actually do?
A Qualified Person (QP) is the individual legally authorized to certify that a batch of medicinal product has been manufactured and tested in accordance with EU GMP and the terms of the relevant marketing authorization, before it can be released for sale or clinical use. The role is established under EU Directive 2001/83/EC, Article 51, and the QP is personally accountable for every batch they certify.
In practice, a QP:
- Certifies each batch prior to release for sale or clinical trial use
- Confirms ongoing compliance with GMP and the site's manufacturing licence
- Reviews deviations, out-of-specification results, and CAPA actions before sign-off
- Acts as the primary contact for regulatory authorities during GMP inspections
- Signs the batch release documentation, including the Certificate of Conformance
The qualification bar is high
Article 49 of the same directive sets out strict eligibility criteria: a university degree in pharmacy, chemistry, biochemistry, medicine, or a related discipline, combined with at least two years of practical experience in pharmaceutical manufacturing or quality control. Registration with the relevant national authority (the IGJ in the Netherlands) is also required before someone can act as QP.
Why QPs are difficult to find and expensive to hire
Because the role combines rare technical depth, legal accountability, and regulatory judgment, QPs are in short supply relative to demand. In the Netherlands, QP salaries typically range between €6,000 and €12,000 gross per month, depending on experience, scope of responsibility, and company type. For smaller biotechs or CDMOs scaling up manufacturing, hiring a permanent QP is not always the right first step; an interim QP engagement to cover an inspection or a leave of absence is often more practical.
A QP's sign-off is only as reliable as the quality system underneath it. We covered that broader culture of demonstrable reliability in how GMP compliance gets protected, and how QP roles fit into the wider QA career ladder in Quality Assurance in Life Sciences: Career Paths, Responsibilities, and Salary Benchmarks.
Working with SIRE on QP recruitment
SIRE Life Sciences maintains a specialist network of certified QPs across the Netherlands, for both permanent placements and interim coverage during inspections or leave replacement.
FAQ
Can anyone become a QP? No. Beyond the required education, practical pharma experience and registration as QP with the competent authority (the IGJ in the Netherlands) are mandatory.
Can a QP be hired on an interim basis? Yes, hiring a QP through secondment is common for temporary projects or bridging periods.
This article is adapted from SIRE Life Sciences' original article, Wat is een Qualified Person (QP) in Farma?
Top comments (0)