CSV Compliance & PM - St Gallen

Lieu: Switzerland - St Gallen

Fonction: Quality

Niveau de Séniorité: Specialist

Votre profil

Vifor Pharma, a world leading Nephrology, Iron Deficiency and Cardio-Renal pharmaceutical company, is experiencing rapid growth due to pipeline realization and optimization.

We are currently looking for a CSV Compliance & PM for our St. Gallen location (hybrid working model). In this position you will be reporting to the QM System Compliance Group Leader. 

Key Tasks
  • Support the implementation and operation of GxP relevant IT systems (incl. IT software and hardware) as QA Manager and ensure the CSV Compliance of the corresponding IT systems
  • Support the creation and update of System related SOP’s (User Manuals, SysOps, …)
  • Plan, conduct and report internal periodic system reviews as Lead or Co-Auditor
  • Plan, conduct and report audits of external IT vendors and service providers
  • Support or lead received quality audits and inspections from an IT QM perspective
  • Manage projects related to QM Systems (QMS, Content Management, LMS, …) as PM-B
Qualifications

Minimum Requirements
  • Required: Bachelor’s degree in Natural Sciences or IT
  • Minimum of 2 years overall experience within the pharmaceutical, biotechnology, or medical device industry
  • Demonstrated practical experience in IT implementation projects considering GxP-compliance aspects like validation, qualification and DI.
  • Subject Matter knowledge regarding Quality Processes (e.g. deviation management, document management, change management, …)
  • Experienced in leading Project Teams (esp. during IT implementation projects). 
Preferred Requirements
  • Lean six sigma/operational excellence qualifications/experience
  • Enhanced SME regarding Quality Applications (e.g. QMS, Content Management, LMS)
  • Enhanced understanding of current IT technologies and related industry standards
  • Strong communication / language skills (English), German is nice to have

A propos de nous

Le groupe Vifor Pharma est une entreprise pharmaceutique internationale spécialisée. Son ambition est de devenir le leader mondial dans les domaines de la carence en fer, de la néphrologie et des traitements cardio-rénaux. L’entreprise est le partenaire de choix pour les médicaments et les solutions innovantes axées sur le patient. Le groupe Vifor Pharma aspire à aider les patients du monde entier atteints de maladies graves et chroniques à mener une vie meilleure et plus saine. La société développe, fabrique et commercialise des produits pharmaceutiques offrant des soins de précision aux patients. Le groupe Vifor Pharma occupe une position de premier plan dans toutes ses activités clés. Il se compose des entreprises suivantes: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma (sa société commune avec Fresenius Medical Care); et OM Pharma.

Le groupe Vifor Pharma a son siège en Suisse et est coté à la Bourse suisse (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).

Pour de plus amples informations, veuillez consulter www.viforpharma.com/career

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