Cadre Assurance Qualité Bpf H/F Sanofi

Détail du poste

Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l'international, l'anglais étant la langue de travail.

This job offer is accessible to all, regardless of gender.

About the Role

This position is responsible for implementing and monitoring the quality assurance system within the GMP Operations sectors of the Synthetics Scientific Platform and Quality Control in Montpellier, ensuring compliance with current regulatory standards including Good Manufacturing Practices (GMP).

Key Responsibilities :

Operational Quality Assurance

Represent Quality Assurance within :
- Analytical Sciences Department
- Physico-chemical laboratories (Quality Control)
- Pharmaceutical Sciences Department

Audit and approve :
- Manufacturing Masters and Technical Conditions
- Manufacturing batch records for GMP Operations sector
- Oversee bulk product manufacturing (primarily oral forms) conducted internally or externally
- Draft Quality Agreements for manufacturing subcontractors
- Participate in preparing regulatory authority inspections
- Coordinate and evaluate investigations following anomalies and/or process deviations
- Approve Change Controls in dedicated IT applications
- Draft, review and approve operating procedures
- Conduct self-inspections and external audits
- Deliver Quality training
- Initiate and/or participate in quality improvement projects
- Participate in lot recalls in collaboration with involved departments

QP Release
- Perform release of investigational medicinal products (bulk products)

Project Support
- Serve as Quality representative in CMC Synthetics project teams for assigned projects

About you

Qualifications :

Education
- Doctorate in Pharmacy required

Experience

Experience in pharmaceutical development and/or Quality Assurance, including :
- Operational Quality Assurance
- Project Quality representative
- Batch release
- CMC activity or CMC quality monitoring

Required Skills
- Mandatory Qualification : Doctor of Pharmacy degree
- Proficiency with IT tools
- Experience working in cross-functional projects or missions
- Fluency in both written and spoken English necessary for the role

Knowledge Areas
- Good understanding of GxP regulations
- Knowledge of Pharmaceutical Development processes
- Experience with subcontracting management

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La diversité et l'inclusion sont les piliers de la manière dont Sanofi fonctionne et font partie intégrante des valeurs de la société. Nous respectons la diversité de nos collaborateurs, tout comme celle de leurs parcours et expériences. Afin de bénéficier de la richesse qu'apporte la diversité, Sanofi s'engage à donner l'exemple en matière d'inclusion et à favoriser un environnement de travail où les différences peuvent prospérer et contribuer à aider les patients à retrouver une vie meilleure.

Dans le cadre de son engagement diversité, Sanofi accueille et intègre des collaborateurs en situation de handicap.