Manager, Aq, Validation - Seneffe, België - Thermo Fisher Scientific

Thermo Fisher Scientific

Geverifieerd bedrijf

Seneffe, België

6 dagen geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

Mission of function

Production of biopharmaceutical production conform to the requirement of international quality defined by the FDA, the EMEA, the ICH, etc.

Context of position and function

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

The production activities need to be executed in an effective and efficient way to guarantee the global competivity of the sites.

Besides, due to the very high value of the products, the activities need to be executed in a highly controlled way.

The control of the production activities and the rules, regulation and cGMP directives compliance are essential for the client's products adequation and the site operating license.

The principal contacts are within its own department. Qualification and validation activities needs to be executed efficiently in order to assure systems compliance and maintenance.***
Principal areas of responsabilities

Strategic axis

Develop maintenance/validation/qualification strategies in order to achieve system compliance
Escalate critical/major events to hierarchy
Management of his/her allocated budget

Operational Axis

Manage validation/qualification activities with a quality assurance point of view (equipment, rooms, utilities, methods,)
Process validation is out of scope
Collaborate with operational teams to be present on the floor for all needs
Review all validation documents : protocols, testing sheets, reports, event sheets
Approval of all documents related to validation : URS, DQ, Risk analysis, supplier dossier
FAT, SAT , IQ, OQ, PQ
Manage documentation related to quality control, maintenance, qualification and validation in conformity to rules and regulations
Define and follow validation strategies with each departments (VMP approval)
Be an active participants to global quality tasks : deviations, CAPA, change controls, risks analysis, internal audit

Team Management Axis

Lean and manage technicians/specialists teams
Ensure daytoday tasks of his/her team
Manage ressources to ensure correct execution of the priorities
Establish matrices for his/her team in agreement with their tasks
Take care of the training (theoretical, soft ans hard skills) of his/her collaborators
Define and follow KPIs
Ensure reporting for followed projects as requested

Documentation Axis

Approval of procedures
Follow quality systems : SOP, CAPA, deviation, change controls,

Contact with the authorities

Support and active participation to the audits and inspections

Complexity of the function

Organisational skills: Management / Priorisation/ coordination of several activities ;
Technical skills : qualification/validation
Communication: Multidepartemental interactions
Managerial skills: motivation / autonomy / responsabilisation / coaching

Knowledge and level of education

Master or engineer in a life science discipline
Minimum 8 years of proven experience in a pharmaceutical experience, added
Viral vectors manufacturing processes knowledge is an asset
CDMO proven experience is an asset
Fluent in French and Englisj, both written and oral is crucial
High knowledge in GMP, GDP & quality systems implementation (Eudralex volume 4 annexe 11/ 15, 21 CFR Part 210 / 211 / 11, ICH Q7, Q9)
Strong skills like communication, influencing, problemsolving are expected
MS Office Suite (Excel/Word/Powerpoint), Outlook, Trackwise, SAP, MS Project
Embodies our Thermo Fisher values of integrity, involvement, intensity and innovation