For our client in Stein we are looking for a Quality Manager, Teamleader QA for a 5-month contact.
Duration: 02.10.2017- 31.03.2018
Supervision of routine and stability testing for sterility, bioburden and bacterial endotoxin tests as microbiological analyses of sterile / low bioburden drug products and drug substances in time and in accordance to cGMP rules, QMs, SOPs and analytical test procedures.
* Supervision of routine and stability testing for microbial enumeration test as microbiological analyses of non-sterile drug products and drug substances in time and in accordance to cGMP rules, QMs, SOPs and analytical test procedures.
* Supervision of microbiological method validation/suitability studies. \
* Ensure correct and timely investigation of microbiological deviations and other deviations (or OOE/OOS results) which influence the microbiological release of sterile/none sterile drug products and drug substances.
* Provides direct support to his team and decision making and oversight to ensure compliance to all standard operating procedures and documents.
* Preparation and support of authority inspections and participation as a microbiological expert.
* Manage the administrative aspects of the group by ensuring the preparation of job descriptions, performance management plans and conducting employee performance reviews.
* Collaboration on local projects.
* University or academic degree in microbiology, biochemistry, pharmacy or equivalent
* Minimum of 5 years relevant experience in the pharmaceutical manufacturing industry with at least 3 years in a leadership or supervision position
* Experienced understanding of cGMPs and other regulatory guidelines applicable to the pharmaceutical industry
* Fluent in German and English (spoken and written)
For more information, please contact:
Anna Chmura firstname.lastname@example.org
Harvey Nash AG
Anna Maria Chmura
+41 44 296 8844