As QA Operations Specialist you will provide the link between the Quality Control operations and the quality system to safeguard the quality, safety, and efficacy of pharmaceutical products and the cGXP conditions. Moreover, you will be the on-the-shopfloor QA partner for the QC team.

RESPONSIBILITIES

Within the Quality System scope, you will:

  • Provide on the floor QA support by advising and counseling on cGMP/cGLP 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 QC 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
  • Participate in self-audits, customer audits, and health authority inspections

Within the Quality Control scope, you will: 

  • Review and approve operational documentation for completeness and compliance to cGMP/cGLP in line with regulatory requirements and internal procedures
  • Issue and oversee the appropriate use of QC records including methods and equipment qualification
  • Advice the Qualified Person on potential quality issues and disposition decision

Within Material System scops, you will:

  • Review and approve incoming materials documentation
  • Release of incoming materials upon review of documentation

QUALIFICATIONS AND SKILLS

  • 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
  • 5 years of hands-on GMP experience in pharmaceutical QA, QC, MS&T, or sterile manufacturing environment
  • Experience with typical QC methods in the biotech environment: Elisa, SDS Page, PCR, in-vitro potency,…
  • Experience with digital QA and paperless QC approach
  • Outstanding Problem-solving skills  (incl. use of investigation techniques)
  • Strong teamwork attitude
  • Able to define pragmatic solutions within the pharmaceutical regulatory framework
  • Fluent in French and English