CSV Compliance & PM

Lieu: Switzerland - St Gallen

Fonction: Quality

Niveau de Séniorité: Manager

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 to join us on a temporary basis for 12 months contract.

Main Accountabilities
  • GxP relevant IT Systems (Hardware and Software) are implemented and operated in accordance to applicable internal and external CSV guidelines/standards
  • SOPs related to IT Systems are always up to date and consider applicable internal and external CSV guidelines/standards
  • Internal IT systems, as well as external IT vendors and service providers are audited against applicable internal and external CSV guidelines/standards
  • Inspection readiness of IT systems (and its associated CSV documentation)
  • Managed projects are delivered (if not reasonably justified) in time, in budget and with the expected benefit
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
  • Support the completion/managing of tasks related to the global Data Integrity Program
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)
Key Measures of Success
  • Assurance of conformity of IT systems to internal and external CSV guidelines/standards.
  • Projects are well managed as PM-B and status reports are provided in a clear and easy understandable way.
  • Successful collaboration with all stakeholders within and outside Quality Management (e.g. with the IT department during IT projects) 
  • Able to allocate his/her own time and resources in a reasonable and efficient manner and in alignment with input from line manager

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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