Hays

Quality Assurance Expert (m/f/d)

Hesse | Employment with Hays Professional Solutions GmbH
Reference number
421424/1
Start date
asap
My duties
  • Updating the existing QM system (GMP compliance)
  • Creation, review and approval of manufacturing and testing protocols, superordinate SOPs and validation documents
  • Editing changes and deviations (CAPA, Change Control, Batch Record Review)
  • Preparation of plans, protocols for all qualification and validation (analytics, equipment, plants, process)
  • Creation and evaluation of risk analyses for process validations
  • Contact for production and laboratory staff regarding equipment, equipment qualification and method validation
My qualifications
  • Minimum B.Sc in biochemistry, pharmacy, biology or equivalent
  • Professional experience in cGMP regulated biopharma industry, preferably with in-depth experience in Quality & Compliance
  • Broad practical routine in representing Quality & Compliance in CAPEX projects from planning to successful health authority inspections
  • In-depth knowledge of engineering & manufacturing processes within large scale Stainless Steel
  • Knowledge of international laws, regulations and requirements for the production of active ingredients (biologics focus), US / EU GxP regulations
  • Strong decision making, analytical skills and the ability to manage multiple projects at the same time
  • Fluent communication skills both in English and German
My benefits
  • International company
About Hays
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays

My contact person
Charlene Wunsch

Reference number
421424/1

Contact
Phone: +49-621-1788 - 2242
E-Mail: charlene.wunsch@hays.de