Computer System Validation and Records Manager - Limited to 2 years - St. Gallen

Location: Switzerland - St Gallen

Function: Quality Management

Company: Vifor Pharma

Kira Maurer

Junior Talent Acquisition

+41 58 851 83 48

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About You

We are currently looking for a CSV and Records Manager to join our Tech Ops team in St. Gallen. You will support the Corporate Records Manager and report directly into the Head of Corporate Quality IT. In this role your tasks will include the following:

As CSV Manager (main tasks approx. 80%):
  • Provide administrative and user support for Quality-relevant corporate IT-Systems as part of the Power User role
  • Take over workflow and functional roles in this context (e.g. QA Assistant in eDMS, Application Manager Business for LMS) 
  • 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)
  • Help ensure a compliant validation status of Quality-relevant corporate IT Systems
  • Help ensure the inspection readiness of Quality-relevant corporate IT Systems
  • Conduct and support IT vendor, contractor and supplier audits initially as co-auditor and after a training phase as lead auditor
  • Present and defend the Corporate QM systems, corresponding validations and requirements during inspections and customer audits
As Records Manager (secondary task approx. 20%):
  • 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)
  • Support to maintain the global Vifor Pharma Archiving and Records Management Standards in Corporate Policies
  • Support the roll out of these standards to the local Quality Units

To be successful in this role, you bring the following profile:
  • 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
  • Work experience with the implementation and maintenance of Quality Systems
  • Basic knowledge with the implementation of Records Management Programs
  • Sound knowledge in document management
  • Auditing experience, experience with Health Authorities Inspections
  • Demonstrated ability to successfully collaborate across different sites, functions, management levels
  • Good English and German language skills (written and spoken)
  • Good knowledge of Microsoft Office Applications (e.g. Word, Excel, PowerPoint, Visio)
  • Education as a Program and/or Project Manager is a plus
  • Language skills in French is a plus
  • Knowledge in GCP, GVP, GDP and or Medical Device requirements would be an advantage
  • User or Key User know-how for Content Server, Trackwise and other GxP-regulated Systems would be an advantage
You are a multitasker with an accurate and thorough working style. You have the ability to effectively communicate with your great project management, organisational and planning skills and you have the ability to work successfully independently as well as in cross functional teams and departments. You bring new ideas and strive to improve and optimise processes with your solution-oriented approach to encourage increased productivity.

About Us

Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company that researches, develops, produces and markets its own pharmaceutical products and is the partner of choice for innovative, patient-focused solutions. The company’s goal is to be a global leader in iron deficiency, nephrology and cardio-renal therapies and strives to help patients around the world with severe and chronic diseases to lead better, healthier lives. Vifor Pharma Group has production sites in Switzerland and Portugal as well as a dynamic network of affiliates and partners offering broad market coverage all over the world. The company has an ever-growing global presence while at the same time remaining firmly rooted in its home market, Switzerland.

Vifor Pharma Group consists of Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, its joint company with Fresenius Medical Care; Relypsa; and OM Pharma.

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