Job Detail

• Job TitleQuality Assurance Specialist


• Vacancy Reference Number16821


• Work SiteSwitzerland / | CHE - All Regions / Basel


• Contract TypePermanent [Full-Time]


• Minimum number of years of experience required5 years of experience and more

Our offer

• A permanent contract with the leader in innovation and high-tech engineering consulting


• A multi-stage model with career opportunities through specialization prospects, as well as with over 45'000 consultants around the world and revenue of EUR. 2.9 Bn, the Altran Group is the undisputed global leader in Engineering and R&D services (ER&D).


• In Switzerland, Altran employs more than 250 consultants and aims towards large growth with offices located in Zürich, Basel, Lausanne and Geneva.


• Altran deploys its expertise particularly in:
  
  
  
  • Life Sciences (Pharma, Biotech, and Medical Devices),
  
  
  • Industry, Aerospace, Automotive, Energy, Railways,
  
  
  • Financial Services: P&C Insurance, Health Insurance, Reinsurance, Banking
  
  
  • Telecoms
  
  
  • Public sector
  
  

Your role

• Initiating improvements to the Quality Management System, ensuring compliance to all relevant quality standards and regulatory requirements


• Surveillance and assistance of development projects with all relevant laws and regulations like for example: cGMP, CFR Part 820 und FDA Guidelines


• Handling Customer complaints


• Investigating deviations and non-conformities in cross-functional teams


• Reviewing batch records and release.

Your profile

• Master Degree / PhD in Pharmacy, Chemistry or Biology (EPFL, ETH,...)


• Minimum 7 years of experience in the regulated pharmaceutical


• Knowledge in Quality control/cGMP


• Experience in SAP et Quality Tools (for ex.FMEA,SPC, etc.)


• Applied knowledge of FDA or Swissmedic and international Pharmaceutical regulations (21 CFR 820, etc.).


• Applied knowledge of the application of advanced quality tools such as Failure Modes Effect Analysis (FMEA), SPC, Root Cause Analysis, etc.


• Languages: English fluent, German is a plus.