Scientist, Engineer - Lead-Auditor Supplier Audits, Pharma (m/f/d)
Posted on Nov 23, 2019 by Aenova Group
for our headquarters in Starnberg, Germany
With a planned turnover of around EUR 750 million in the current financial year, the Aenova Group is one of the leading companies in the global pharmaceutical and healthcare industry. The group's portfolio of services covers the entire value chain for the development and production of all the main dosage forms and product groups in the field of medicines and dietary supplements. The Aenova Group's high standards of quality, innovative technologies and clear vision for the future have enabled it to become European market leader in the business-to-business field. The company, which has its headquarters near Munich, operates 22 sites in ten countries throughout the world. More than 4300 employees contribute to the group's success.
- Independent execution as well as preparation and follow-up of external audits for supplier qualification as lead auditor according to EU GMP Part I & II, Annex I, IPEC, GDP, ISO standard, etc.
- Evaluation and follow-up of CAPA measures from supplier audits
- Scheduling and preparation of planned audits
- Further development of supplier qualification in compliance with valid internationally recognized guidelines and corporate standards
- Support introduction of an electronic documentation and planning tool for audits
- Collaboration on Corporate Quality projects
- Strong communication and argumentation skills in German and English
- High degree of personal responsibility, flexibility and team spirit as well as national and international willingness to travel approx. 80-90 %
- Natural science or engineering studies or comparable education
- At least four years of professional experience in the pharmaceutical or food industry
- Qualification and proven experience as lead auditor
- Extensive knowledge of national and international regulations (e.g. ISO standards, EU-GMP, IPEC, 21CFR, BRC/IFS, etc.)
- Strong communication skills, solution-oriented action, confident appearance and negotiation skills
- Willingness to travel
- Very good MS Office skills
- Business fluent in written and spoken English
We offer a growth-oriented, dynamic and international environment, which offers challenging tasks across the sites as well as active participation opportunities. If these tasks in a future-proof corporate group attract you, then we would like to get in touch with you.