QA Expert
Vor 2 Tagen
Description:
Services: The objective of this resource within the Quality Ops organization is to provide support as a Quality Assurance Senior Expert in the frame of routine GMP operations for Fill and Finishing area. He/she must ensure the quality of information reported within the various systems and documentation with respect to current guidelines, compliance and regulatory requirements.
This resource will be specifically responsible for the following tasks:
- Review of deviations in the framework of production events within quality systems (i.e. Trackwise) to verify acceptability and adherence to standard procedures and regulatory requirements. This includes conducting or approving the relevant investigations, impact assessments (related to impact on concerned equipment/product/material) and definition of relevant CAPA.
- Prepare, evaluate, and approve controlled documentation revision/creation.
- Attend all meetings relevant to perform the above-mentioned tasks.
- Respect the escalation process.
- Ensure completion of relevant training and software access management according to Takeda policies.
- Other tasks related to conventional quality oversight might be occasionally requested to support the team (e.g. continuous improvement initiatives, GMP tour in classified areas, batch review, etc.).
The above-mentioned tasks are site-based and on-site presence is expected. Home office might be allowed occasionally for specific tasks upon request.
Profil recherché
- Formation académique technique et scientifique (bac +5).
- 2-3 d’expériences opérationnelles cGMP dans un département Qualité Ops sur un site de production Pharmaceutique de produits stériles injectables.
- Connaissances holistiques des procédés de production (de la culture cellulaire à la répartition aseptique) : étapes unitaires, équipements, gowning, contrôles d’environnement, tests laboratoires physicochimiques et biologiques, etc.
- Connaissance des référentiels Qualité (cGMP) et des Systèmes Qualité (Déviations, CAPA, Change Control, Training, Documentation, etc.).
- Capacité rédactionnelle pour des documents en français et/ou anglais.
- Langues : français et anglais.
- Travail sur PC et connaissances pack Microsoft.
- Travail en équipe.
- Agilité et autonomie.
Mode de travail:
- Minimum 4 jours sur site.
- Reporting au QA manager, mais travail en interaction quotidienne avec Manufacturing, Engineering, Sterility Assurance, Quality Ops, Training, etc.
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