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Our client – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
You have at least 5 years experience in the Pharmaceutical/Biotech industry with significant experience of GMP ?
The purpose of the role is to assure and maintain the organization of the activities linked to the quality oversight of the manufacturing activities in the new production building of Hepatits A bulk production and in priority the resolution of the deviations and definition and follow up CAPA actions linked to the deviations.
By the quality oversight and deviation follow up of the manufacturing process define action plan in collaboration with the production team to assure that the quality systems are in place and in use to produce consistency batches.
Some responsibilities :
•Ensure follow up of the meetings linked to the deviation handling and support the QA operational team in the organization of deviation review
•Review and approbation of deviations
•Ensure a regular workshop in production areas; verify the respect of GMP and procedures in place and identify gaps/deviations, define action plans in collaboration with the production team
•Participate the implementation of the quality systems in the new production building to assure compliance of consistency campaign and the commercial production
•Give support to the approval of change controls linked to the deviations
• Identify, Develop and Implement improvements to the quality oversight processes
• University degree: master degree in Sciences/Engineering e.g. Pharmacist / Master in Sciences / Bio Engineer pharmaceutical • Minimum 5 years in the Pharmaceutical/Biotech industry with significant experience of GMP • French fluent and professional English is a plus • Preferred knowledge of vaccines and/or immunology process and products (manufacturing)
what do we offer?
We offer an attractive salary with extra-legal advantages :
- Group insurance - Hospitalisation insurance - Meal vouchers of 7 euros gross per working day - Reimbursement km or company car - Monthly allowance (50 euros net per month) - A 13th month - Training - Etc.