IT Quality CSV

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.