Interim Qualified Person services
PCS offers interim Qualified Persons for product release in the EU.
Over 25 satisfied clients preceded you!
We are a pharmaceutical consultancy firm dedicated to your people, the patient and the process. Are you looking for a Qualified Person or other interim staff? We have the expertise and network to provide you with highly qualified candidates.
Looking to contract an interim Qualified Person? Plan a free consult! After the consult 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.
Curious to see how we can help you find an interim Qualified Person? Plan a free consult today!
We have two types of interim Qualified Persons available. Depending on your requirements, budget and current QP staffing, you may require a senior QP or a trainee QP.
Junior
Trainee interim Qualified Persons
Trainee Qualified Persons can support your Qualified Person, while training the junior to become a fully qualified Qualified Person. A cost-effective way to get extra capacity in the batch release process.
Senior
Senior interim Qualified Persons
The Senior Qualified Person is a fully qualified and trained QP. The Senior Qualified Persons PCS offers are highly experienced and can either support your current QP or be added to your manufacturing & import license as primary QP.
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, if the QP is already qualified.
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.
- 1 Plan a free consult
- 2 Face-to-face or online meeting
- 3 PCS finds suitable candidates
- 4 Meet & greet with candidates
- 5 Final selection
- 6 Contractual matters
- 7 QP starts working!
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;
Qualified Person Education
PCS offers four training modules offering an integrated approach to quality management in pharma and biotech, and in hospitals, to safeguard the quality of their products.
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.
