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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
Project Support
About you
Qualifications:
Education
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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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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !
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