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Qualified Person (QP)
Challenging position in an international pharmaceutical packaging organisation
Het bedrijf / The company
The organisation is a global contract packaging organisation (CPO) specializing in primary and secondary pharmaceutical packaging and supply chain management services. They are dedicated to shape the future of the pharmaceutical supply chain to be safer and more reliable for customers and for patients. With more than 30 years of track record in contract packaging, they use their knowledge and experience to offer flexible solutions to customers challenges. Furthermore, they use the latest technologies to continuously improve operations. They now supply products to over 45 countries across all continents. As QP you will be part of the Quality Unit. It is the Quality Unit’s responsibility to make sure that people, processes, materials, and machines work together to assure patient safety. You will be reporting to the Director Corporate Development.
De functie / The role
As a Qualified Person, you will be combining pharmaceutical product release with quality project work. You will be part of a dynamic, fast-paced, and innovation-inclined Quality Assurance team, consisting of three QA Managers. The QA team is responsible for defining evidence-based quality standards, contributing to the robustness, efficiency and effectiveness of production and back-office processes and methods. Members of the QA team combine project-based work with operational release and approval work. Currently, the QPs are responsible for the release of +3000 different products (SKUs). As a member of the team, you will have expert pharmaceutical knowledge, and draw on your experience to develop, implement and deliver excellent quality services. As such, you will have a direct impact on the success of the organisation and on the safety of the patients. As part of your work, you will also be working in multi-disciplinary teams with partners from across the internal supply chain, communicating with local and international customers, and playing an integral part in the market delivery of complex and innovative pharmaceutical products that make a real difference to patients’ lives. You will participate in releasing pharmaceutical packaging and products into the market, assessing APIs, PPMs, and cleaning validations and supporting over ten new product implementations per year. Furthermore, in this role you will work closely with other teams within Quality to lead, execute and monitor strategic QA projects. In addition, you will work closely with Commercial to enable an efficient and effective onboarding of new pharmaceutical products. Lastly, you will work closely with Operations Management to ensure the suitability of packaging materials and their shelf-life.
Het profiel / Your profile
• M.Sc. (or equivalent) in a pharmaceutical-related subject
• More than 3 years of experience as a Qualified Person (QP)
• profound familiarity and in-depth experience with EU cGxP and FDA regulations
• familiarity and experience with additional foreign GMP regulations (e.g. Russia, Brazil, China) is an advantage
• demonstrable experience with investigating, defining, and resolving complex issues
• good professional and interpersonal communication skills; both oral and written in both Dutch and English
Het aanbod / The offer
• a diverse job at a pharmaceutical packaging organisation
• working at a stable and growing organisation
• a personal development plan to become successful
• freedom to work independently
• good working conditions
Reactie / Reaction
Interested? Please send your resume and motivational letter by e-mail, with reference to WL/21-045-FMF, to Pieter van Gelderen: email@example.com.
For further information, please call Pieter van Gelderen at number +31 (0)33 472 80 87.
Tenslotte ..... / Finally ....
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.