Website headcount AG

Senior Quality Assurance Manager CSV – 12 months

headcount AG is a Zurich-based consultancy serving clients in the pharmaceutical, biotechnology, medical technology, diagnostic, OTC and chemical market segments.

Our client is a leading pharmaceutical company, specialized in the discovery, development and commercialization of small molecules. 

RESPONSIBILITIES

_Ensure all computerized systems are compliant within the company.

_Function as contact person for Pharmaceutical Development & System Project Team.

_Function as Pharmaceutical Development representative in updating  internal systems inventory.

_Train key stakeholders in CSV & data integrity.

_Assist in validation & data integrity master plan preparation.

_Function as Lead Auditor & represent the company during  internal/external audits.

REQUIREMENTS 

_ Master’s degree or equivalent 

_≥ 7 years experience in CSV

_Solid understanding of regulatory requirements (GxP,  21 CFR Part 11 etc.)

_Solid understanding of data integrity in pharmaceutical industry (regulations & 
expectations)

_Fluent in English

***Please forward your application should you meet the requirements above – applications which do not meet these requirements will not be considered***

headcount AG
Alexander Schanne

Dreikönigstrasse 55
8002 Zürich
alex@headcount.ch
http://www.headcount.ch

 

 

 

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