Head Quality Assurance Stability Sterile Manufacturing

Schweiz, Aargau, Kaiseraugst FHLR

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• Job facts

Head Quality Assurance Stability Sterile Manufacturing

The Head of Quality Assurance Stability is a member of the QA Sterile Manufacturing leader ship team and a business partner to the Quality Control. In this role the of Head of Quality Assurance Stability is responsible for the GMP-compliant design, implementation and evaluation of stability studies as part of the annual stability tests as well as process changes of solid and parenteral drug products and will contribute in several areas:

• Leading a team of Quality professionals, which includes handling all aspects of the Employee Performance Management lifecycle including hiring and performance management and development planning


• Attending staff meetings and be expected to provide input to the strategic direction of the QA Organization


• Be responsible for monitoring and correcting performance in all Key Performance Indicators established for the QA Stability organization


• Active collaboration for transfers and new product introduction related to stabilities, local and global


• Provide technical and quality guidance and direction to ensure GMP compliance


• Partner with Quality Control personnel to ensure a constant state of inspection readiness by identifying, bringing up and collaborating to resolve compliance risks


• Be the Single Point of Contact for communication and strong partner with Global Stability group

You are someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

In order to be successful in this role you have the following qualifications:

• Advanced university degree in Pharmacy or alternative technical/science university degree, preferred with PhD. At least 8 years of experience in pharmaceutical industry, preferred with some experience in Quality Control and / or Quality Assurance


• Several years of experience in leading people


• Sound knowledge of analytical testing of products as well as E2E understanding


• Strong knowledge of GMPs, ISO and other international regulations for the pharmaceutical industry


• Experienced in continuous improvement


• Audit- and Inspection experience


• Experience in risk and project management


• Excellent English and German language skills

If you still have questions then please check our FAQs and videos on careers.roche.ch/faq.

• Who we areBei Roche leisten 94,000 Menschen in 100 Ländern Pionierarbeit im Gesundheitswesen. Gemeinsam haben wir uns zu einem weltweit führenden, forschungsorientierten Healthcare-Konzern entwickelt. Unser Erfolg baut auf Innovation, Neugier und Vielfalt.
  
  Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.


• Job facts
  
  
  
  • Location Schweiz, Aargau, Kaiseraugst FHLR
  
  
  • Function Quality
  
  
  • Subfunction Quality Assurance
  
  
  • Schedule Vollzeit
  
  
  • Job level Team Leader
  
  
  • Job type Unbefristet
  
  
  • Division Roche Pharmaceuticals
  
  
  • Posted since 2019/01/15
  
  
  • Job-ID 201812-131602
  
  


• Get in touchMrs. Hanna Funke


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