Our client, a pharmaceutical company headquartered in Switzerland , is looking for a CSV and Records Manager for a 24 months contract based in Eastern Switzerland.
The ideal candidate will support the Corporate Recrods Manager and report directly into the Head of CorporateQuality IT.
Computer System Validation Manager
Provide administrative and user support for Quality-relevant corporate IT-Systems as part of the Power User role;
Support the development, validation, implementation and maintenance of Quality-relevant corporate IT-Systems and process workflows across multiple sites and functions;
Support of CSV (Computerised System Validation) projects in the assigned role (QA Manager and/or Business Project Manager);
Support the Corporate Records Manager during definition, implementation and roll out of the global Records Management program (define corporate standards and support related projects from a business perspective);
Conduct and support IT vendor, contractor and supplier audits initially as co-auditor and after a training phase as lead auditor;
Support to maintain the globalArchiving and Records Management Standards in Corporate Policies.
Qualifications and Experience:
Bachelor Degree in Pharmacy, Chemistry, Chemical Engineering, Science or similar;
1 - 3 years’ work experience in a QA, QC or QM department in the Pharmaceutical, Chemical and/or Medical Device Industry would be beneficial;
Work experience with the validation of Computerised systems;
Basic knowledge with the implementation of Records Management Programs;
Sound knowledge in document management;
Good English and German language skills (written and spoken), French is a plus;
Knowledge in GCP, GVP, GDP and or Medical Device requirements would be an advantage;
Education as a Program and/or Project Manager is a plus;
Relevant working/residency permit or Swiss/EU-Citizenship required.