Overview
Quality Assurance Engineer Jobs in Lausanne, Vaud, Switzerland at Milestone Research
Title: Quality Assurance Engineer
Company: Milestone Research
Location: Lausanne, Vaud, Switzerland
Our client is a Swiss consulting company with an experienced team of Life Sciences professionals. They deliver outstanding industry’s expertise and support to their clients in the complete range of product life cycle
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Responsibilities
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),
Qualifications
At least 5 years of 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.
Excellent written & oral communication skills.
Languages: English (fluent), French and/or German is a big plus.
