Quality Assurance Engineer

Job Description

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

Benefits

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.