Technicien Assurance Qualité Terrain Senior - Horaire 2x8 - H/F (CDI)
On-siteStrasbourg, Grand Est, France
Job Summary
Review production documentation, conduct line clears, and serve as the primary quality interface with operations teams for production, maintenance, and QC. Track corrective actions, ensure data integrity and Good Documentation Practices, and review cleaning documentation. Coach operators to improve quality culture by identifying field-based non-conformities and lead continuous improvement initiatives. Manage deviations, changes, CAPAs, and represent the Quality Assurance function in internal audits, external audits, and regulatory inspections. Draft, review, and approve procedures and work instructions. This senior role reports directly to the QA Operations Manager at PolyPeptide's Strasbourg site, supporting clients in the pharmaceutical and biotechnology sectors from preclinical to commercial stages.
Required Qualifications
- BAC+2 ou BAC+3 dans le domaine scientifique idéalement Chimie / Pharma
- solide expérience dans une fonction similaire
- expérience terrain
- expérience terrain et qualité opérationnelle indispensables
- en industrie pharmaceutique
- Maîtrise des référentiels EuGMP et ICHQ7
- Maitrise de la suite Office (Excel, ...)
- des systèmes qualités
- Rythme en horaire posté 2x8
Desired Qualifications
- la connaissance d'autres référentiels (diagnostiques, cosmétiques...)
- est un plus
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