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 DepartmentPhysico-chemical laboratories (Quality Control)Pharmaceutical Sciences Department

Audit and approve:

Manufacturing Masters and Technical ConditionsManufacturing batch records for GMP Operations sectorOversee bulk product manufacturing (primarily oral forms) conducted internally or externallyDraft Quality Agreements for manufacturing subcontractorsParticipate in preparing regulatory authority inspectionsCoordinate and evaluate investigations following anomalies and/or process deviationsApprove Change Controls in dedicated IT applicationsDraft, review and approve operating proceduresConduct self-inspections and external auditsDeliver Quality trainingInitiate and/or participate in quality improvement projectsParticipate 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 AssuranceProject Quality representativeBatch releaseCMC activity or CMC quality monitoring

Required Skills

Mandatory Qualification: Doctor of Pharmacy degreeProficiency with IT toolsExperience working in cross-functional projects or missionsFluency in both written and spoken English necessary for the role

Knowledge Areas

Good understanding of GxP regulationsKnowledge of Pharmaceutical Development processesExperience with subcontracting management

Pursue Progress. Discover Extraordinary. 

 

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together. 

 

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. 
 

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! 

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!