Sr QA Specialist
il y a 4 semaines
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
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