QC Team Leader Microbiology (Cgmps/QMs/SOPs) Pharma Know-How (Ref.Nr

QC TEAM LEADER MICROBIOLOGY (CGMPS/QMS/SOPS) PHARMA KNOW-HOW

BRINE SA has been placing top IT specialists at well-known customers for over 30 years. In doing so, we focus on performance, competence, experience and partnerships.

BRINE SA is looking for a QC TEAM LEADER MICROBIOLOGY (CGMPS/QMS/SOPS) PHARMA KNOW-HOW role:

MAJOR ACCOUNTABILITIES

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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.
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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.
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Supervision of microbiological method validation/suitability studies.
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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.
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Provides direct support to team and decision making and oversight to ensure compliance to all standard operating procedures and documents.
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Preparation and support of authority inspections and participation as a microbiological expert.
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Manage the administrative aspects of the group by ensuring the preparation of job descriptions, performance management plans and conducting employee performance reviews.

MINIMUM REQUIREMENTS

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Pharma Know-How REQUIRED!
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University or academic degree in microbiology, biochemistry, pharmacy or equivalent
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Minimum of 5 years relevant experience in the pharmaceutical manufacturing industry with at least 3 years in a leadership or supervision position
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Experienced understanding of cGMPs and other regulatory guidelines applicable to the pharmaceutical industry
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Fluent in German and English (spoken and written)

To learn more about this opportunity please send your CV ASAP in Word format to BRINE SA.

WORK LOCATION: Basel

START: October 2017

DURATION: 6 months

WORKLOAD: 100%

SALARY: Local Market rate according to experience

PERMIT: EU permits

REF. NR.: HS2264

BRINE SA has been providing its IT- and SAP specialists for short-, mid- and long-term projects in Switzerland since 1985, with customers primarily active in the following market sectors:

Financial services sector, especially banks and insurance companies

Pharmaceutical industry

Government and services sectors

BRINE SA is a stable, financially independent, Swiss enterprise with its head office in Zurich. Our services cover the entire IT spectrum, as well as interfaces to the various business sectors, and range from management- and IT-consulting through to software development and project implementation.

IT - RESOURCES

We offer our top consultants, computer Profi's and SAP experts to our customers as external specialists for limited assignments and as well for permanent positions. BRINE SA is especially distinguished by its renowned characteristic strengths:

Short reaction time - rapid selection and supply of consultant's CVs, with skills matched to customer requirements.

Quality - we take quality very seriously, both for internal and external-facing processes, thereby convincing many customers to maintain a long-standing business relationship with BRINE SA

Coaching - BRINE SA coaches and supports its consultants throughout the entire duration of the customer assignment.

BRINE SA is ISO 9001:2008 certified since 2014