Our world needs ideas! As one of the world’s most research-intensive chemical companies, we have been developing leading solutions for numerous sectors – from construction to photovoltaics and cosmetics to rubber – for over 100 years. We have a global presence with production sites on three continents and about 14,500 employees from 70 nations.
Wacker Biotech, as part of WACKER, is a leading global biotechnology organization specializing in the production of biopharmaceuticals. The company has outstanding technologies for the rapid, efficient and thus cost-effective production of therapeutic proteins for clinical and commercial supply. Currently it is the biggest dedicated microbial Contract Development & Manufacturing Organization (CDMO) in the world. Its four dedicated and fast-growing production sites are currently based in Germany (Halle and Jena), The Netherlands (Amsterdam) and The United States (San Diego, CA).
Are you looking for a dynamic, globally active technology company – yet at the same time, you appreciate a value-oriented, trusting company? We offer you exciting work as part of a team of experts who treat each other as equals. At our Amsterdam-based center Wacker Biotech B.V. focuses on the GMP-compliant microbial based production of recombinant proteins, vaccines and live microbials as drug substance and drug product.
We are currently looking for a Qualified Person (f/m/d) to join our growing team.
For more detailed information please feel free to contact Mrs. Peggy Engels, tel. 0031 (0)20 7503 675.
Please note: Agency acquisition to this vacancy is not appreciated.
Job responsibilities:
- Releasing both Investigational medicinal as well as Medicinal products as well as related materials and components according to applicable legislation and Marketing Authorisation / CTA;
- Approval of the documentation related to and production materials (raw materials, starting materials), labels and packaging materials, semi-finished products (intermediates), active pharmaceutical ingredients (API.s), final products and products;
- Register, calculate, check, and assess production data of the activities/ tasks for which the QP is authorized in a manner that is accurate, timely, complete, is factual and clear;
- Keep quality oversight on all operational activities;
- Act as focal point for quality issues and resolution, eg. Deviations, CAPA, Change Control, QAA's etc.;
- Have quality control carried out under cGXP, as appropriate per project;
- Critically review investigations, interpret results and generate conclusions regarding product and facility impact;
- Manage the Pharmaceutical quality system of Wacker Biotech B.V. and report KPI's, trends, deviations to management in a timely manner;
- Ensure compliance with Pharmaceutical legislation and regulations as well as CTA's, IND, BLA's etc. and marketing authorisations;
- Represent Wacker Biotech B.V. during inspections of inspectorates and other competent authorities and conduct their associated correspondence and administration;
- Have any Recalls carried out according to procedure.
Qualifications required:
- University degree; eligible as QP as defined per EU directive 2001/83/EC, Eudralex volume 4, Annexes 13 & 16 and other applicable regulations;
- Minimum of 5 years of relevant (managerial) experience as Qualified Person in the (bio)pharmaceutical industry;
- You reside in and are eligible to work in The Netherlands (valid work permit).
WACKER, as an innovative chemical company, makes a vital contribution toward improving the quality of life around the world by developing intelligent solutions for sustainable growth. Our culture focuses on building and retaining diverse and inclusive teams. WACKER offers a great work environment, professional development, challenging careers, competitive benefit offerings and beyond through giving back to our communities.
Be part of our WACKER family. Across all nations.
We are looking forward to your online application at www.wacker.com/careers.
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