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Qualiy Assurance Specialist ( M/F)

October 15th 2020

At Univercells, we are on a mission to make health equally accessible to all. We work every day to reinvent biomanufacturing processes, and develop or integrate the next innovative technologies. Through the combination of process development and engineering expertise, we create synergies to deliver game-changing production capacities to achieve our mission: Biologics available and affordable to all!

Mission Description

  • Quality point of contact for all operations related-activities: deviations, change requests, CAPA, documents review, incoming inspection….
  • Responsible for performing internal audits in logistics, manufacturing and quality control to ensure the processes are in place & in use
  • Improve current processes in place to ensure an increase of quality level with real added value for the company.
  • Write procedures & training material defining quality systems to implement in operations
  • Review & approve procedures and work instructions defining logistics/manufacturing/quality control activities
  • Release of products (equipment for biotechnologies) after a thorough review of production documentation
  • QA stakeholder for manufacturing improvement projects
  • Technical visit of key suppliers to ensure they provide the right quality level
  • Support of product managers to define & write quality-related documentation for customers
  • As part of QA team, you’ll be process owner of 1 or more quality processes
  • Support to peers in the quality team when necessary

Candidate profile

  • MSc in Life Sciences, Bio-Engineering, Engineering or related field
  • At least 5 years of experience working in biotechnology/pharmaceutical company (in a GMP environment) or as a supplier for those companies
  • Experience working with ATMPs is an asset 
  • Experience working in operations is an asset
  • Experience in change management is an asset 
  • Strong in communication and team player
  • Good influential skills
  • Ability to work in fast-paced environments and to combine helicopter view and tactical actions
  • Fluent in French and Englis

Offer

For more informations please contact to Univercells

Contact Details

 interested? please apply here