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Quality Manager
Eingestellt von Harvey Nash IT Recruitment Switzerland
Gesuchte Skills: Support, Client
Projektbeschreibung
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/her 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 (see below)
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/her 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 (see below)
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Sonstiges