Offer
- challenging position with broad responsibilities within pharmaceutical quality and compliance
- opportunity to contribute to quality improvements, product launches and international operations
- room for professional and personal development within a growing organization
Position
As Senior Quality Assurance Lead / QP & RP at Eurocept Pharmaceuticals, you will be responsible for maintaining and improving pharmaceutical quality and compliance. You work within a close-knit Quality team and report to the Director Quality & Compliance. In this position, you combine Quality Assurance leadership with responsibilities as QP and RP. You ensure that pharmaceutical products meet applicable GxP and regulatory requirements before market release.
You develop and improve the Quality Management System (QMS), including SOPs, deviations, CAPAs and change controls. Furthermore, you will coordinate internal and external audits, support regulatory inspections and manage supplier and customer qualifications. Also, you oversee quality agreements and investigate quality issues to identify root causes and implement sustainable improvements.
In addition, you will be responsible for batch certification, Product Quality Reviews (PQRs) and ongoing stability studies. You monitor out-of-specification results and oversee narcotics management, including regulatory reporting. You support new product launches and work closely with internal departments and international partners. Through training, guidance, and continuous improvement initiatives, you contribute to a strong quality culture. In short, a broad senior quality position combining operational responsibility, regulatory expertise and leadership.
Profile
- master’s degree in Pharmacy, Chemistry, Life Sciences or a related scientific discipline
- certified Qualified Person (QP), preferably with experience as Responsible Person (RP)
- at least 3 years of experience in pharmaceutical quality management, including leading quality initiatives and teams
- extensive knowledge of GMP, GxP regulations, pharmaceutical quality systems and regulatory compliance
- experience with QMS development, audits, inspections, CAPAs, change controls and risk assessments
- strong analytical, problem-solving, and decision-making skills, combined with a structured approach
- excellent leadership, communication, and project management skills, with a strong sense of business awareness
- proficient in English, both written and spoken
Organisation
Our client, Eurocept Pharmaceuticals, is a growing international pharmaceutical organization founded in 2001. Its headquarters are located in Ankeveen, with an additional logistics facility in Hilversum. The company operates internationally through local representatives and partnerships.
Depending on the product, Eurocept acts as marketing authorization holder, manufacturer, local representative, distributor, or wholesaler. Its activities include pharmaceutical registration, pharmacovigilance, manufacturing, marketing, sales, and distribution.
Quality, regulatory compliance and customer satisfaction are central to the organization. Eurocept continuously strives to meet the highest pharmaceutical standards while expanding its international activities. The Senior Quality Assurance Lead / QP & RP plays a significant role in supporting these ambitions and further strengthening the Quality department.
Response
Interested? Please send your resume and motivational letter by e-mail, with reference to WS/26-237, to Dennis Uleman: info@derksenderks.nl.
For further information, please call, text or WhatsApp to Dennis Uleman at number +31 6 82 72 71 33.
An individual assessment may be part of the selection procedure.
Our client has chosen Derks & Derks B.V. as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.
Not quite the position you are looking for? Please check our website https://www.derksenderks.nl/vacatures/ for other interesting positions!
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