Qualified Person Ankeveen • Derks & Derks

Vacature in het kort

Volledige vacaturetekst

• 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. Specifically, this position focuses on compliance activities in line with GxP requirements and regulatory standards. As a result, you will ensure that products meet all necessary criteria before reaching the market.

In this role, you will be responsible for a diverse range of tasks. For instance, you will take ownership of CAPA management, handle deviations, perform internal audits, and oversee the creation and review of Product Quality Reviews (PQRs). Additionally, you will ensure the proper execution of batch releases and validate production protocols. To succeed in this position, a minimum of three years of experience as a Qualified Person (QP) is essential, as this is a core requirement of the role. Although an RP certification is considered a valuable asset, it is not mandatory.

Moreover, you will be part of a dedicated team within the Quality Department. Specifically, you will collaborate closely with two other QPs at the headquarters while supporting the Director of Quality & Compliance. Furthermore, 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 its dual focus. On the one hand, you will work closely with the product lifecycle and influence critical processes within the production environment. On the other hand, you will engage in both strategic and operational quality tasks. For example, you will conduct internal audits and act as the primary QA point of contact for your assigned products.

• 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, and Eurocept also owns 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.

Interested? Please send your resume and motivational letter by e-mail, with reference to WS/24-383, to Bjorn Schouten: via de button "Solliciteer nu" op deze pagina..

For further information, please call Bjorn Schouten at number .

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Tagged as: Life Sciences