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Henkel
- Quality Manager
Düsseldorf
2015 - 2015
Transfert de technologie de l'Italie, des US, d'Anvers (Belgium) pour plus de 70 spécialités différentes
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CAF-DCF-Sanquin
- Project Engineer
2013 - 2015
Improvement of HVAC group - upgraded classification for production area.
* Study of flow, power of existing group.
* Thermal coefficient of the system.
* Balancing.
* Part of commissioning and validation group.
* Qualification Final Reports.
* Hand-over.
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Baxter International
- Validation Engineer
Maurepas
2013 - 2013
Implementation of loader and unloader robot: end of the project:
* Part of the PQ and post-PQ team.
* Qualification Reports.
* Hand-over.
Implementation of an Automatic Guided Vehicles system
* Check of the technical documentation and contacts with the provider.
* FAT testing.
* Writing, testing and reports for IQ, OQ, PQ including CFR21part11 compliance.
* Updating of quality documentation (SOP, forms, Operating Instructions, …).
* User’s Training.
* Qualification Final Reports
* Hand-over.
Improvement of two mixing-filling lines
* FAT FSDS and Engineering testing.
* Writing, testing and reports for IQ, OQ, PQ, PPQ..
* Updating of quality documentation (SOP, forms …).
* User’s Training.
* Qualification Final Reports
* Hand-over.
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UCB
- Senior Engineer
COLOMBES
2012 - 2012
* Process Engineer.
* C&V of laboratory and plant equipment :
o ASTM E2500.
o Study of choice of all the equipment
o documentation review and acceptance
o validation tests control
* spot check regarding risk assessment
* reports review
* hand-over
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Besins Manufacturing
- Senior Engineer
2011 - 2012
Engineering and Maintenance Manager
1. Maintenance of two bulk manufacturing units and four filling and packaging lines.
2. Building maintenance:
3. Improvement project management:
* Revamping of compressed air loop. ;
* Implementation study of two reverse osmosis units. ;
* Classification of a bulk manufacturing unit and improvement of personnel and material flux.
* Implementation of a new tube filling machine on an existing packaging line.
* Implementation of datamatrix and sequential check. ;
* Quality and technical audits. ;
* URS, DQ, FAT, SAT, IQ, OQ, PQ and reports.
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GlaxoSmithKline
- Pharmaceutical Filling Supervisor
Marly-le-Roi
2009 - 2011
Aseptic Filling of vaccines
Team: 25 people
* Management of the filling of syringes on two filling lines.
* Management of the filling of vials for liquid or freeze dried vaccines.
* Management of the filling of tubes.
* Environmental Monitoring. ;
* Preparation and sterilizations of small materials. ;
* Preparation and sterilizations of bulk tank. ;
* Sterilization of isolators: VHP. ;
* Sterilization of syringes, vials... before use: anti-pyrogénic tunnel, electron beam sterilization
tunnel...
* Housekeeping supervision.
* Writing of SOPs. ;
* Management of all technical aspect: HVAC, facilities... ;
* Technical training for people concerned.
* Change control initiation and follow-up.
* CAPA plan establishment and follow-up. ;
* Visual inspection and calibration of these facilities (Bosch).
WORK ENVIRONMENT
DURING THE NIGHT SHIFT, I WAS RESPONSIBLE OF APPLICATION OF CGMP, SOP, FOR ALL THE TEAM.
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Cenexi
- Pharmaceutical Production Supervisor
Fontenay-sous-Bois
2005 - 2009
Aseptic filling of cytostatics - Packaging
* Management of the filling of vials for liquid or freeze dried cytostatics. ;
* Environmental Monitoring.
* Bulk preparing. ;
* Preparation and sterilizations of small materials. ;
* Preparation and sterilizations of bulk tank. ;
* Cleaning and sterilization of isolators. ;
* Sterilization of vials before use: anti-pyrogénic tunnel. ;
* Housekeeping supervision.
* Writing of SOPs.
* Technical training for people concerned.
* Change control initiation and follow-up.
* CAPA plan establishment and follow-up.
* Lyophilization receipt: improvement. ;
* Technical knowledge of freeze dryer: compressor, vacuum pump, exchange facilities, pressure
rising test, leak detection techniques...
* Management of utilities: water for injection, breathable compressed air, HVAC... ;
* Visual inspection: semi automatic facilities (Optrel). ;
* Review of raw data, justification of OOS, out of trends, last reviewer before PhD's approving.
WORK ENVIRONMENT
DURING THE WEEK-END, I WAS RESPONSIBLE OF APPLICATION OF CGMP, SOP, FOR ALL THE TEAM. I `D TO MANAGE
ALL THE PLANT AREA ON SECURITY ASPECT: INTRUSION, FIRE ALERT, INJURED WORKERS, QUALITY DECISION,
SUPPPLY, AND ALL PROBLEMS YOU CAN MEET WHEN YOU ARE ALONE ON THE WEEK-END IN A PRODUCTION PLANT.
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UCB
- Chemical Production Engineer
COLOMBES
1992 - 2005
Synthesis of APIs
* Human resource management: implementation of the continuous working: 125 workers
organized in 5 teams. Negotiation with workers representative.
* Managing a fleet of 150 equipments: track maintenance and repair. ;
* Row material management.
* Cash charge of production cost. ;
* Creation of a database for production management. ;
* Take part of FDA's agreement improvement.
* Planning of production. ;
* Responsible of inside customer's satisfaction. ;
* Housekeeping supervision.
* Writing of SOPs.
* Technical training for people concerned.
* Change control initiation and follow-up.
* CAPA plan establishment and follow-up. ;
* Review of raw data, justification of OOS, out of trends, last reviewer before PhD's approving.
