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Quality Assurance Engineer, Le Mont-sur-Lausanne Client: The French Sourcer
Location: Le Mont-sur-Lausanne
Job Category: Other
Job Reference: e5cd2e40a70a
Job Views: 7
Posted: 08.02.2025
Expiry Date: 25.03.2025
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 ensure the execution and 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 in 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 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's Degree (or equivalent) in Life Sciences or a related discipline.
Thorough understanding of cGMPs, Eudralex, and FDA 21 CFR regulatory requirements.
Languages: English (fluent), French and/or German is a big plus.
Very competitive compensation package with exceptional Pension scheme - 5 weeks paid holidays - ongoing Training & Development opportunities.
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