interim Responsible Person

Hourly basis, flexible contracts for experienced RP's

For pharma logistics, warehousing and 3PL's

Need an interim Responsible Person on your GDP license?

PCS provides interim RP's (responsible persons) for logistical companies dealing with medicinal/pharmaceutical products. If you are looking for flexibile Responsible Person services, PCS is your partner.

We offer flexible RP services. Only pay for hours worked. 24/7 Availability through backup-RP's and more than thirty years of experience. So if you're looking for a Responsible Person on your wholesale license, we will provide the right person for the job.

Our clients

Join dozens of pharmaceutical and logistics companies who use our RP services.

Otsuka Pharmaceuticals NL

PCS provides Responsible Services for Ostuka Pharmaceutical Netherlands. The project involved obtaining a Wholesale Distribution License (WDL) and to implement a local GDP quality system to Dutch government requirements. The Dutch entity allows Otsuka to distribute products to Europe post Brexit.

Esna Health

For Esna Health PCS implemented a GDP quality system to obtain a GDP license in the Netherlands. The GDP license was succesfully obtained in 2021 with no minor/major/critical observations from the Dutch regulatory authority IGJ. PCS will continue to provide RP services now that the license is obtained.

XinHua Europe

For XinHua Europe, a trading company in medicinal products, PCS helped to improve the existing quality system to a GDP for API quality system. Designated Person (DP) services are included in the quality system upgrade package.

VISUfarma

For VISUfarma, an ophthalmic specialty pharmaceutical company, PCS implemented a GDP quality system whilst providing backup RP support. A GDP/WDL license was succesfully achieved and the company is able to distribute their products throughout the European Union.

the wholesale distributor must designate a person as responsible person.

~ Chapter 2, article 2.2 of the EU-GDP Guidelines (2013/C 343/01)

Can anyone become a Responsible Person?

It should be possible for anyone to become a Responsible Person. There are some requirements to be fulfilled however:

  • A degree in pharmacy is desirable

  • The responsible person should have appropriate competence and experience as well as knowledge of and training in GDP

  • The responsible person should fulfil their responsibilities personally and should be continuously contactable.

For detailed Responsible Person requirements, refer to directive 2013/C 343/01 of the European Commission.

What are the responsibilities of a Responsible Person?

In general, the Responsible Person has the following responsibilities:

  • Maintain a pharmaceutical Quality System, including records

  • Ensure that continuous GDP training programs are implemented and maintained

  • Handling/performing recalls, complaints and supplier approvals

  • Approve subcontracted activities and ensure GDP compliance of internal audits

  • Deciding on the final disposition of returned, rejected, recalled or falsified products

How do I contract a PCS RP?

The first step is to get in touch with us. You can use our contact page or use the form at the bottom of this page. When you get in touch, list;

  1. Your activities
  2. Product type (steriles, cold-chain, etc.)
  3. Amount of hours needed per week

When we receive your email we will propose any candidates we may have, their availability and rate. After that we will have a meet and greet with each candidate, followed by a discussion and an official offer.

Can we discuss our need in more detail?

We are happy to e-meet you and discuss your Responsible Person needs. By filling in the form below you can reserve a timeslot in our agenda. We hope to talk to you soon!

Book a meeting now, quick and easy!

We are ready to help, let's get in touch!

Get in touch by sending us a message

Or have a look at our most popular products