Manager, Aq, Validation

il y a 4 semaines

Seneffe, Belgique Thermo Fisher Scientific Temps plein

**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 day-to-day 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: Multi-departemental 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, problem-solving are expected
- MS Office Suite (Excel/Word/Powerpoint), Outlook, Trackwise, SAP, MS Project
- Embodies our Thermo Fisher values of integrity, involvement, intensity and innovation

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