Quality Assurance Engineer
Vor 7 Tagen
- 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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