PCS offers interim Qualified Persons for product release in the EU.
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We will quickly find a suitable and qualified Qualified Person for you! We usually respond within the hour.
With more than 30 years of experience in the pharma and biotech industry, we have a wide network of interim Qualified Persons for both small and large companies.
Whether you are looking for a primary or backup QP, PCS has the experience to get you the right person, quickly and accurately.
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.
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 call 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.
The Qualified Person is the cornerstone of pharmaceutical assurance, bridging science with safety to protect public health.
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;
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.
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.
The qualified person shall reside in the European Union.
We charge an hourly fee for the interim Qualified Person, plus travel costs (if any). Every QP is different, and so is their level of experience. Different QP's have different hourly rates. You only pay for hours worked, which are invoiced monthly. We always agree on a maximum number of hours in each contract, deviations, however might be necessary when mandatory GMP tasks or responsibilities need to be performed such as a complaint investigation for example.
On average, we need about two to three weeks to find you any number of candidates; depending on the complexity of your product and supply chain. In most cases - a Qualified Person should be found within the aformentioned timeframe. Some complex product groups such as ATMP's / IMP's may require a longer timeframe. PCS will continually inform you of the progress of our search.
The number of hours an interim Qualified Person needs differs for every company. In some cases, the QP needs no more than 16 hours per month, in others the QP may need 56 hours per month. The recommended minimum is twelve hours per month to allow the Qualified Person to fulfill the required GMP tasks and responsibilities.
Yes. PCS provides free replacement of the interim Qualified Person. We will find the most suitable candidate and propose this candidate Qualified Person to you. If possible, the old QP will perform the transfer of tasks & responsibilities. If the old QP is incapacitated, we will find a suitable solution free of charge.
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.
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