Qualified Person
- fully responsible for a portion of Eurocept’s portfolio from a QA perspective
- oversee compliance activities within the Quality Department of a successful Dutch company
- certify pharmaceutical products and meet all required quality standards
- be part of an entrepreneurial, diverse company culture that fosters innovation
As a Qualified Person at Eurocept Pharmaceuticals, you will play a crucial role in ensuring the release of high-quality pharmaceutical products. This position focuses on compliance activities in line with GxP requirements and regulatory standards, ensuring that products meet all necessary criteria before reaching the market.
In this role, you will take ownership of a diverse range of responsibilities, including CAPA management, handling deviations, performing internal audits, and overseeing the creation and review of Product Quality Reviews (PQRs). Additionally, you will ensure the proper execution of batch releases and validate production protocols. Experience as a Qualified Person (QP) for a minimum of three years is essential, as this is a core requirement of the role. While an RP certification is considered a valuable asset, it is not mandatory.
You will be part of a dedicated team within the Quality Department, collaborating closely with two other QP’s at the headquarters and supporting the Director of Quality & Compliance. The broader team structure includes a QA Manager who supervises three QA Officers, ensuring a robust quality framework across the organization.
What makes this role unique, and rewarding is the opportunity to work closely with the product lifecycle and influence critical processes within the production environment. You will engage in both strategic and operational quality tasks, such as conducting internal audits and acting as the primary QA point of contact for your assigned products.
Profile
- at least a Bachelor’s degree in Life Sciences (e.g., Chemistry, Pharmacy, or other related fields)
- 3+ years of experience as a Qualified Person in the pharmaceutical industry
- in-depth understanding of GxP regulations
- independent, analytical, and communicative
- problem-solving abilities and a result-oriented mentality
- strong communication skills in English (being able to speak Dutch is a preference, not a requirement)
Eurocept Pharmaceuticals is a successful Dutch company that has been active in the pharmaceutical sector since 2001. The company is characterized as a medium-sized business with short communication lines between various departments. Their mission is to bring medicines to the market that facilitate the therapeutic relationship between healthcare providers and patients. The head office is located in Ankeveen, with offices in Paris and Istanbul. Depending on the market and the services provided, Eurocept Pharmaceutical Holding also operates under the well-known brand Lucane Pharma, primarily for rare disease indications. Depending on the product, Eurocept Pharmaceuticals acts as a marketing authorization holder, manufacturer, local representative, distributor, or wholesaler. In all these different areas, Eurocept Pharmaceuticals delivers high-quality products and services while meeting the high expectations of customers and the requirements as laid down in regulations (GMP/GDP). As a wholesaler and manufacturer, the company is responsible for regulatory affairs, quality, pharmacovigilance, production, marketing, sales, and distribution of medicines in many countries worldwide. Eurocept Pharmaceuticals values diversity, and their work environment can be described as informal, dynamic, and entrepreneurial.
Response
Interested? Please send your resume and motivational letter by e-mail, with reference to WS/24-383, to Bjorn Schouten: bjorn@derksenderks.nl.
For further information, please call Bjorn Schouten at number +31 6 516 491 61.
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Tagged as: Life Sciences
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Senioriteitsniveau
Medewerker -
Soort baan
Fulltime -
Functie
Kwaliteitsborging, Productmanagement en Supply chain -
Bedrijfstakken
Geneesmiddelenproductie, Groothandel levensmiddelen en dranken en Internationale handel en ontwikkeling
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