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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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