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

Lieu: Switzerland - St Gallen

Fonction: Quality Management

Compagnie: Vifor Pharma

Kira Maurer

International Talent Acquisition Specialist

+41 58 851 83 48

Conditions pour les agences de placement

Votre profil

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.

A propos de nous

Le Groupe Vifor Pharma, anciennement Groupe Galenica, est une entreprise Specialty Pharma mondiale qui se consacre à la recherche, au développement, à la fabrication et à la commercialisation de ses propres produits pharmaceutiques. Il est le partenaire de choix pour les solutions innovantes axées sur le patient. L’entreprise, qui entend devenir le leader mondial des traitements de la carence en fer et des affections néphrologiques et cardio-rénales, aspire à aider les patients du monde entier souffrant de maladies graves et chroniques à mener une vie meilleure et plus saine. Le Groupe Vifor Pharma possède des sites de production en Suisse et au Portugal, ainsi qu’un réseau dynamique de sociétés affiliées et de partenaires lui assurant une vaste couverture de marché dans le monde entier. L’entreprise affiche une présence mondiale en constante augmentation mais conserve de solides racines dans son marché d’origine, la Suisse.

Le Groupe Vifor Pharma est constitué de Vifor Pharma, de Vifor Fresenius Medical Care Renal Pharma – sa société commune avec Fresenius Medical Care –, de Relypsa et d’OM Pharma.

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Conditions pour les agences de placement