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Quality Assurance Operations Lead (M/F)

November 30th 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

Manager of a small team: ensure team spirit, define priorities, ensure objectives are achieved
With your team, you’ll be responsible of the following: 
Quality point of contact for all operations related-activities: deviations, change requests, CAPA, documents review, incoming insection….
responsible of 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 increase of quality level with real added value for the company.
release of products (equipment for biotechnologies) after 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 manager to define & write quality-related documentation for customers
write procedures & training material defining quality systems to implement in operations
review & approve procedures and work instructions defining logistics/manufacturing/quality control activities
As part of QA team, you’ll be process owner of 1 or more quality processes
support of peers in the quality team when necessary

Candidate profile

  • MSc in Life Sciences, Bio-Engineering, Engineering or related field
  • At least 8 years of experience working in biotechnology/pharmaceutical company (in a GMP environment) or as supplier for those companies
  • Experience working with Gene therapy 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 English.

 

Offer

For more informations please contact to Univercells

Contact Details


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