IT Quality CSV

Eastern Switzerland
07 Dec 2018
11 Feb 2019
Contract Type

Main Responsibilities:

  • 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.

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