Job Description

　　The site is a biopharmaceutical multi-product and multi-client’s site with development and producing facilities of pharmaceutical products for both clinical trials (phase I, II and III) and commercial applications.

　　This type of facility needs to be conformed to the rules et regulation of the BPF established by the ministers of health and the social protection of countries, as well as the international directives.

　　The manufacturing activities are executed in an effective and efficient way to guarantee the global competitivity of the sites. Besides, due to the very high value of the intermediate products and products, the production activities need to be executed in a highly controlled way. Take part to the business entity’s growth by ensuring high value products disposition in a controlled manner ! Be key in processes compliance by following daily routine of the manufacturing steps and associated services while partnering and interacting with qualified person and other relevant key positions in various departments!

　　Operational axis

　　Own compliance for the task assigned

　　Coordinate review and approval of

　　operational documentation related to project

　　documentation linked to executed activities (media, assemblies, campaign, risk analysis, ..)

　　documentation in order to release the manufactured batches to prepare QP releases

　　quality records (deviation, change control, capa…) in trackwise

　　Be fronter in gouvernance meeting with projects managers and clients

　　Play as a partner on all production matters

　　Maintain the site master files and related procedures (for activities under their responsibilities)

　　Make assurance of the compliance of the reviewed documents to current rules

　　Oversight documentation from initiation to archiving (Issues Print, reconciliations, …)

　　Be on the floor during critical manufacturing steps

　　Respect and share data integrity rules (ALCOA+)

　　Participate to internal/External audits/inspections

　　Operational Excellence

　　Develop / Build performance culture with their colleagues in quality but in all departments

　　Make proposal to improve flows, manufacturing activities and organisation

　　Use tools defined by Thermofisher group

　　Investigate root causes and implement adequate corrective actions

　　Background and skills

　　Graduate in scientific field with at least 5 years in the pharmaceutical environment

　　Knowledge of cGMP, good written skills (French and English), agile and analytical approach

　　CDMO and/or gene therapy experience are assets

　　Suite MS Office (Word – Excel – Powerpoint), SAP, Trackwise, Documentum

　　Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.