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GlaxoSmithKline
- Coordinateur validation
Marly-le-Roi
2012 - 2012
Management responsibilities (3 persons)
Responsible for coordination of validation activities relative to bulk project and routine activities.
- Cleaning
- Sterilisation
- Media bulk / media formulation
- Buffer and media management (sterile hold time, cold chain)
- HVAC
- Computerized systems
Connexion between production, Calibration & measurements and QA departments.
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Tescom
- Qualification engineer
Puteaux
2009 - 2009
Mission in LFB (Lille)
Involved in Quality assurance / validation department, I was in charge of the retrospective qualification of laboratory equipments like freezers, laminar air flow, equipments to make dilutions.
I had to check documentation and testing performed at their installation and check if they were in accordance with the current regulations.
I was in charge as well to follow the cleaning validation process. First of all I was in charge of making a listing of all the equipments and check their cleaning process.
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Tescom
- Qualification engineer
Puteaux
2009 - 2011
Global Computer Validation coordinator in GSK Bio (Wavre)
Job description: follow up of projects including process control parts (Empower 2, different analytical equipments, water loops, weigh scales, monitoring systems …).
As a member of a global structure I am in charge of reviewing standard documents (procedures, IQ-OQ templates).
Meeting with other sites. Follow up of supplier audits. Development of decommissioning strategy for QC equipments.
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Tescom
- Qualification Engineer
Puteaux
2008 - 2009
Mission in UCB Pharma (Braine l'Alleud) from November 2007 to May 2009
This job aims to ensure that all equipments (manufacturing, packaging fields...) are compliant with all regulations.
This job is interconnected with several departments of the company (quality assurance, production, metrology ...).
When discrepancies are discovered, as a qualification engineer I have to ask for these missing informations and follow the quality of the information given.
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Impac Engineering
- Qualification Engineer
2007 - 2008
Integration of the qualification-validation department for UCB Pharma
My missions :
- Produce qualification protocols, testing and finally reports relative.
- Follow solving of discrepancies
- Be in accordance with internal procedures and external regulations
- Check if all the documentation required is available and ask for it if not
- Redaction of instructions (=user manual) for a production equipment
Fields : production equipments (reactors, dryers and their driving software ...)
Skills :
- Be able to centralise all the information from the different departments
- Summarize the informations
- Work in straight collaboration with other departments
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Sanofi Pasteur
- Assistant qualification
Lyon
2007 - 2007
Integration of the qualification department.
My missions :
- Produce qualification protocols, testing and finally reports relative.
- Follow solving of discrepancies
- Be in accordance with internal procedures and external regulations (European Pharmacopeia, American Pharmacopeia ...)
Fields : laboratory equipments : HPLC and its software, ELISA devices, spectroscopy
Skills :
- Teamleading : be in charge of 2 technicians when the testing should be carried out
- Organisation of meetings with suppliers of new equipments
