22 days ago

Quality Manager

Harvey Nash AG

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Quality Manager

For our client in Stein we are looking for a Quality Manager, Teamleader QA for a 5-month contact.

Place: Stein

Duration: 02.10.2017- 31.03.2018

Workload: 100%

Major Accountabilities

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.

Minimum requirements

* 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 anna.chmura@harveynash.com

+41(0)43-508-8642

Harvey Nash AG
Anna Maria Chmura
+41 44 296 8844