Expert Quality Manufacturing Science API & Raw Material - St Gallen

Ort: Switzerland - St Gallen

Funktion: Technical Operations

Senioritätslevel: Senior Manager

Ihr 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 

Über uns

Die Vifor Pharma Gruppe ist ein globales Spezialitäten-Pharmaunternehmen. Sie hat sich zum Ziel gesetzt, globale Marktführerin in den Bereichen Eisenmangel, Nephrologie und kardiorenale Therapien zu werden. Das Unternehmen ist der bevorzugte Partner für Pharmaprodukte und innovative, patientenorientierte Lösungen. Die Vifor Pharma Gruppe will Patienten mit schweren und chronischen Krankheiten auf der ganzen Welt dabei helfen, ein Leben in besserer Gesundheit zu führen. Das Unternehmen entwickelt, produziert und vermarktet pharmazeutische Produkte für eine optimale Patientenversorgung. Die Vifor Pharma Gruppe nimmt in allen ihren Kerngeschäften eine führende Position ein und besteht aus folgenden Unternehmen: Vifor Pharma, Vifor Fresenius Medical Care Renal Pharma (ein gemeinsam mit Fresenius Medical Care geführtes Unternehmen); und OM Pharma.

Die Vifor Pharma Gruppe hat ihren Hauptsitz in der Schweiz und ist an der Schweizer Börse (SIX Swiss Exchange, VIFN, ISIN: CH0364749348) kotiert.

Weitere Informationen finden Sie auf www.viforpharma.com/career

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