Expert Quality Manufacturing Science API & Raw Material - St Gallen

Lieu: Switzerland - St Gallen

Fonction: Technical Operations

Niveau de Séniorité: Senior Manager

Votre profil

At Vifor Pharma we are looking to establish a new organisational model to manage important Contract Manufacturing Organization (CMO) partnerships. In this context, we have an exciting opportunity as Expert Quality Manufacturing Science API & Raw Material in St. Gallen. In this role you will report into the Head of Quality Operations External API & Oral Products and you will be responsible for ensuring product knowledge within Vifor for providing best support for our CMOs and analytical service providers. 

Main Accountabilities:
  • Ensure knowledge management for APIs, raw materials and packaging materials of Oral products  together with CMOs/suppliers or external analytical service provider
  • Ensure manufacturing and analytical method expertise
  • Taking care of successful implementation of product knowledge into Q Operations Oral products
  • Manage stability studies for APIs (Plan, Report)
  • Manage on-going stability studies for APIs (Plan, Report)
  • Leading Problem solving, root cause analysis & continuous improvement activities with internal and external parties
  • Coordination and handling of relevant processes, change controls, deviations, implementations, validations and documents for CMOs/suppliers in cooperation with other Vifor departments (Supply Chain, Regulatory, ext. development, QP, …)
  • Support handling of relevant deviations and complaints acc. defined process
  • Quality Assurance representative and project team member in projects including CMOs for oral products, if applicable
  • Reporting of PQRs for APIs
  • Support KPI Management, provide reports, tracking KPIs for evaluation of performance of CMOs/suppliers
  • Providing oversight to product-related data
  • Support for regulatory submissions
  • Ensure internal and external stakeholders engagement and alignment, working cross functionally with various teams in the organisation 
  • Ensure timely and functional communication 
  • Coordination and handling of relevant processes, change controls, deviations, implementations, validations and documents for CMOs/suppliers in cooperation with other Vifor departments (Supply Chain, Regulatory, ext. development, QP, …)
The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge, or the equivalent.

Minimum Requirements
  • Bachelor/Master Degree in Life Sciences or related industries or working experience in pharmaceutical Industry
  • Minimum 5 years overall experience within the pharmaceutical, biotechnology, or medical device industry
  • Experience in Quality Control, Manufacturing or Stability Management, API, excipients, packaging material
  • Very good troubleshooting, problem solving skills
  • Extended scientific knowledge
  • Experience in lean management tools and Operational Excellence
  • Understanding of GxP & other relevant regulations
  • Fluent German/English 
Preferred Requirements
  • Working experience in different cultures
  • Working experience in Pharmaceutical/Analytical Development
  • Audit experience
  • An additional language (e.g.  French) would be an asset 

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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