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).