Quality Assurance Engineer

Vor 7 Tagen


Le MontsurLausanne, Waadt, Schweiz The French Sourcer Vollzeit
The French Sourcer is seeking a Quality Assurance Engineer. Our client is a Swiss company composed of a passionate team of experienced Life Sciences professionals. Since 2014, they have been providing expert support across the entire product lifecycle, including R&D, engineering, quality management, regulatory affairs, manufacturing, and project management. Recognized as a leader in the Life Sciences market, they are known for their deep industry expertise and commitment to excellence. 
  • Perform QA reviews for qualification and validation documentation (DQ, IQ, OQ, PQ, process validation)
  • Handle deviations, CAPA, and Change Control and ensures the execution and the follow up of escalation processes
  • Review batch records (electronics or paper)  for API, Raw materials, bulk, semi-finished / finished products)
  • Write and assist with writing SOPs and further documents for QA.
  • Handle the approval and qualification of suppliers, bulk, packaging services including participation to auditing and establishing Technical/Quality Agreements.
  • Actively contribute to Product Quality Reviews (PQR), Continuous Process Verification (CPV); and to investigations as needed
  • Ensure successful Authorities inspections by participating in the preparation and the support in different roles (i.e. Backoffice, Subject Matter Expert, Scribe or Runner).


Requirements
  • Experience in Quality Assurance in a pharma or biotech company.
  • Master Degree (or equivalent) in Life Sciences or a related discipline.
  • Thorough understanding of cGMPs, Eudralex, and FDA 21 CFR regulatory requirements.
  • Excellent written & oral communication skills.
  • Languages: English (fluent), French and/or German is a big plus.


Benefits
  • Very competitive compensation package with exceptional Pension scheme - 5 weeks paid holidays - ongoing Training & Development opportunities...



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