JOBS

Back

QA Operations Specialist – Exothera (H/F/X)

March 26th 2021

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

In relation to the Quality system you will:

  • Provide on the floor QA support by advising and counseling on cGMP and related quality assurance issues to the value stream
  • Establish, implement, maintain and continuously improve QA Operations documents and documentation
  • Initiate, participate, document, review, and approve operational risk assessments
  • Take initiative to resolve deviation and OOS situations, participate in related investigations and review and approve related reports
  • Review and approve change requests, related actions plans, and documentation
  • Participate and provide training of personnel in relation to quality and cGMP requirements, both in classroom and shopfloor environment
  • Perform annual product review activities
  • Participate in self-audits, customer audits, and health authority inspections
  • In relation to the Production System you will:
  • Review and approve operational cGMP documentation for completeness and compliance to cGMPs in line with regulatory requirements and internal procedures
  • Issue and oversee the appropriate use of batch records
  • Examines and evaluates production documentation, including batch records, in-process results, and other relevant production documentation; advice the Qualified Person on potential quality issues and disposition decision
  • In relation to the Materials System you will:
  • Review and approve incoming materials documentation
  • Release of incoming materials upon review of documentation

Candidate profile

We are looking for new colleagues with these required skills to support our ambitious goals:

  • MSc or equivalent in a scientific discipline, engineering, or related discipline with the required skills, knowledge, and abilities that are typically acquired through experience in a biopharmaceutical manufacturing environment with cell culture activities.
  • 2 – 5 years of hands-on GMP experience in pharmaceutical QA, QC, MS&T, or sterile manufacturing environment
  • Experience with single-use processes and equipment 
  • Experience or are highly interested in digital QA approach
  • Moreover, you possess excellent problem solving (and master quality investigation techniques) 
  • You get energized by Teamwork
  • You are able to define pragmatic solutions within the pharmaceutical regulatory framework
  • You are fluent in French and English (both oral and written)

Offer

For more information please contact to Univercells

Contact Details

Is it appealing to you? Apply now