For Pharma & Biotech

What is a Qualified Person?

The Qualified Person, abbreviated as QP, is mandated by the EU GMP. The QP is responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force in the Member State where certification takes place, in accordance with the requirements of the marketing authorisation (MA) and with Good Manufacturing Practice (GMP).

The Qualified Person is contracted or employed by the manufacturer or importer of medicinal products. Although there is a financial relationship, the Qualified Person is independent. Decisions on batch release should not be corrupted by threaths of employment termination or other financial consequences/motives.

A set of paperwork which is signed and stamped by a Qualified Person

Why you should hire a PCS interim QP

  1. Hiring a Qualified Person is a time consuming process,
  2. There is a big shortage of Qualified Persons in the Netherlands,
  3. Contracts are flexible and you only pay for hours worked,
  4. Our Qualified Persons are highly experienced.

Let's find you a QP!

We will find you a suitable Qualified Person quickly! We usually respond within the hour.

Can anyone become a Qualified Person?

Not everyone can become a Qualified Person. You need to fulfill a number of requirements as dictated in directive 2001/83/EC. These requirements include;

  1. A qualified person shall be in possession of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course of study, or a course recognized as equivalent by the Member State concerned, extending over a period of at least four years of theoretical and practical study in one of the following scientific disciplines: pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology. There are some nuances to this requirement, refer to 2001/83/EC to explore these nuances.
  2. The qualified person shall have acquired practical experience over at least two years, in one or more undertakings which are authorized to manufacture medicinal products, in the activities of qualitative analysis of medicinal products, of quantitative analysis of active substances and of the testing and checking necessary to ensure the quality of medicinal products. The duration of practical experience may be reduced by one year where a university course lasts for at least five years and by a year and a half where the course lasts for at least six years.
  3. The qualified person shall reside in the European Union.

How can I hire an interim Qualified Person?

The first step is to get in touch with us. Go to our contact page to submit a request. You can also use the form below to submit a request.

After you have submitted your request, we will plan a telephone conference to discuss your needs in detail.

After the telephone conference we will explore our immediate network of consultants to find you the right Qualified Person. We will organize a meet & greet with each candidate to see if there's a match.

When there's a match in terms of experience and personality we will send you an offer. Once the offer is approved the QP needs to be trained on your products and procedures. Simultaneously we will start working to add the Qualified Person on your license.

As soon as the QP has been added to your license, he/she can start releasing products.

Let's find you a Qualified Person!

We are a pharmaceutical consultancy dedicated to quality and patient safety. Are you looking for a Qualified Person or other interim staff? We have the expertise and network to provide you with highly qualified candidates.

Feel free to contact us if you have any questions about our Qualified Person services or GMP in general.