- a position where your expertise has great value
- responsible for setting up the QMS while following the EU guidelines
- reporting directly to the CEO
- temporary contract position for 16 to 32 hours per week
- independent role with ranging responsibilities
Through our INRALS-network we received this opportunity in the Netherlands. The client is a UK-based company which is a specialized Pharma company developing products for the life-long treatment of chronic endocrine conditions. It is their mission to meet major clinical and patient needs in hormone replacement, initially by developing and marketing products for the rare orphan diseases. The organisation is currently looking to expand their business to the Netherlands and is therefore looking to meet an enthusiastic and all-round Responsible Person to set up the local quality system.
In the position of Responsible Person you audit and report on the activities of all sites mentioned on the Wholesale Distribution Authorisation (WDA) and ensure compliance with the EU Directive. Specifically, this means that you are called the primary Responsible Person for appropriate sites in the Netherlands. You have a direct reporting line to the CEO but you also collaborate with other RPs.
Other responsibilities include, but are not limited to, ensuring that the provisions of the licences are observed as well as all local regulations and guidelines on GDP are complied. You will also ensure QMS is implemented and maintained. Also, operations need to be aware that there is no compromising in the quality of medicines. Therefor you train all personnel involved in GDP/distribution activities. You make sure that all suppliers and customers are qualified as well as that complaints are dealt with effectively. In conjunction with the recall committee (where applicable) decide on the final disposition of returned, rejected , recalled or falsified products. Therefore you need to be aware of the requirements for falsified medicinal products ensuring adequately procedures to manage any actual or potential falsified medicinal products that are identified in the supply chain. From time to time you provide backup support in case the primary UK’s Responsible Person is not available.
- prior experience (minimum of five years) working in accordance as an RP for GDP including all WDA and QMS oversight responsibilities, regulatory inspection experience etc
- knowledge and experience in Quality Management; familiar with regulatory GDP-procedures
- highly-organised, often taking initiative, with excellent attention to detail, able to produce high-quality work to agreed deadlines and prioritise.
- experienced in computer applications and business software including Excel
- excellent written and verbal communication skills in English and Dutch (both mandatory)
- self-motivated, able to work independently and innovative.
Interested? Please send your resume and motivational letter by e-mail, with reference to DT/20-081-DD, to Sandra van Putten: email@example.com. For further information, please call Sandra van Putten at number +31 (0)33 472 80 87.
Our client has chosen Derks & Derks Secondment & Interim as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.