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ALTRAN
Vélizy-Villacoublay
maintenant
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GlaxoSmithKline
- QA GMP - Lots cliniques - Phase d'industrialisation
Marly-le-Roi
2010 - maintenant
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DeValck Consultants
- Project coordinator
2008 - 2010
BAXTER Pharma – Engineering department – Lessines – Belgium
(DeValck Consultants)
Context and mission:
Intervention date: since Nov-2008
Total work time: Full time.
I work in particular on 1 of the top 5 Baxter’s project from 2008 to 2011 (building from validation).
Rule and responsibilities
o Follow and update the elaborated planning and the people,
o Lead progression meeting daily, weekly, monthly,
o Lead workshops in order to elaborate strategic action plan and put in place methodology in the aim to anticipate possible critical points,
o Communicate information appropriately: highlight, meeting report, presenting.
Results
o Planning elaborated, optimisation is going on
o Project deadline maintained in project buffer
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DeValck Consultants
- QA systeme (production)
2008 - 2008
CATALENT – QA Department – Neder Over Hembeek, Belgium
(DeValck Consultants)
Context and mission:
Solving the non-conformities from production batches before lot release.
Intervention date: From Oct 2008 to Nov-2008
Total work time: Full time.
Rule and responsibilities
o - Risk analysis,
o - Query to determinate the roots cause
o - Corrective and/or preventive action plan defined
Results
o - Non conformities closed and lot released
o - Work with production, QC, validation departments; teamwork in the way to continues improvement.
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DeValck Consultants
- Ingénieur Qualification/ Commissioning
2007 - 2008
UCB Pharma – Engineering department – Braine L’Alleud, Belgique
(DeValck Consultants)
Context and mission:
Prospective qualifications and Commissioning:
- Prospective qualification on mixer tank, grinding,
- Commissioning on dry powder production line modifications (automatisation on mixer, compactor, elevator)
- Change control gestion, commissioning and qualification on caméras of inspection on 3 blister packaging lines
- Building standard protocols for HVAC commissioning
Intervention date: From Apr 2007 to Sep 2008
Total work time: Full time.
Rules and responsibilities:
o Build the testing protocoles and follow the building of the installations
o Performe the testing (quality and technical), work with suppliers
o Follow the non conformities and manage to resolve them on project planification timing (QMP)
Results:
o Write related documents
o Furnish to the production department complet technical folders, and documentation of installations built (advises, testing,
o Proposing appropiate methods to resolve non conformities following the testing results
o Plan and assigne the corrective and preventive tasks (individuals objectives)
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PURAC (Hollande)
- Ingénieur Production/Qualité
2006 - 2006
PURAC Biochem – Quality Environnement Savety and Healt department – Gorinchem, The Netherlands
Context and mission:
Last year internship validating Pharmacy School and Engineer School.
Retrospective qualification and validation of the plant demineralised water installation and distribution system
Intervention date: From Feb 2006 to Aug 2007
Total work time: Full time.
Title: Qualification Engineer
Rule and responsibilities
o Literature study to set up a plan how to perform the qualification.
o Execute an installation and P&ID check.
o Plan monitoring trial.
o Perform of an operators training for sampling.
o Organize the monitoring trial.
o Statistical analyse of the test data’s.
Results
o Report of the results in IOQ and PQ reports conform to the pharmaceutical standards.
o Plan a 6 months additional monitoring trial in supplying installation.
PURAC Biochem – Process Engineering department – Gorinchem, The Netherlands
Context and mission: 2 projects (See below)
Title: Process Engineer
1- Optimisation of fermentation step
Rule and responsibilities
o Check the accuracy of sugar dosing method monitored to finalize the fermentation batches
Results
o Method accurate but not adapted with the fermentation broth.
o Study of different none reacted sugars in process tail time.
o Proposal of a method sugars dosing.
2- Optimisation of purification on carbon; study of colour & odour
Rule and responsibilities:
o Improve the stability of the product.
o Reproduction of the product behaviour in laboratory.
Results:
o Started stability study.
o Monitoring set up to prevent maintenance actions.
o Plant methodology improvement.
o Recommended further improvements.
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De Valck Consultants (Belgique)
- Chargé de qualification
2006 - 2007
UCB Pharma – Qualification department – Braine L’Alleud, Belgique
(DeValck Consultants)
Context and mission:
Retrospective qualification of purified water and WFI installations
Intervention date: From Nov 2006 to April 2007
Total work time: Full time.
Rule and responsibilities
o Performe the IQ testing in the 2 systems
o Defend the documents against Corporate Audit and Lachman Audit
Results
o Write IQ reports and OQ protocols
o Proposing appropriate methods to resolve deviations following the qualification results
o Plan and assigne the corrective and preventive tasks (individuals objectives)
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SOLVAY (Portugal)
- Assistant ingénieur
2005 - 2005
SOLVAY Portugal productos chimicos – Engineering department – Povoa de Santa Iria, Portugal
Context and mission:
Internship validating the third year in Engineer School.
Process optimization: Optimisation and automation of lime slaking step in SOLVAY soda ash process.
Intervention date: From May 2005 to Aug 2005
Rule and responsibilities:
o Identify user-friendly parameters in automation and make proposal for automation.
Results
o Increase of reaction yield.
o Connexion modifications of water pipes and utilities saved.
o Building of new technological montage to perform the automation.
o Automation proposal tested through a manual trial of regulation.
o Driving the initial programming work.
o Further actions recommended and proposal for improvement & exploitation of the regulation.
o Maintenance set up.
o 5 operators trained in new work methods.
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Hopitaux-Officine (Espagne et France)
- Pharmacien stagiaire
2004 - 2004
- Hospital Clinico San Carlos, Madrid-Espagne:
Délivrance d’ordonnances, préparations journalières, gestion de stocks.
- Qualité: l’hôpital de la Conception-Marseille : Analyse des matières premières, control des halogénés.
- Expériences estivales en officine de quartier.
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CRT de Galénique Industrielle-Marseille
- Pharmacien stagiaire
2003 - 2003
Tests de faisabilités pour le développement d’un nouvel antibiotique par inhalation
- Etablissement de tests de faisabilité,
- Expériences en opérations unitaires : broyage, mélange, tamisage,
- Utilisation du granulométre laser Malvern, et de l’échantillonneur Andersen.
Conclusion : tests faisables
