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GSK
- Superviseur
maintenant
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IPL
maintenant
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UCB
- CMC QA Senior Specialist
COLOMBES
2014 - maintenant
Context & mission:
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Any medicine that is authorized on the market is the result of development processes, clinical assays and regulatory submissions. These development processes include the identification and the manufacturing of drug substances (DS) which, once formulated, combined with excipients and threated with additional processes, will become a drug product (DP). Be the Quality Assurance (QA) representative for CMC (Chemistry Manufacturing & Controls) Development activities
Role & responsibilities:
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- Review and approve cleaning verification protocols
- Review and approve cleaning protocols
- Ensure the management of batch disposition and release activities of DS/DP
- Review and approve SOP's and quality documents (i.e: validation report, stability report)
- Ensure the deviation management, the CAPA's follow up and the change controls follow up
- Write and manage Quality Assurance Agreements
- Reinforce partnership between QA and Pilot Plant teams
Results:
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- More than 163 cleaning protocols reviewed
- More than 42 batches reviewed and released
- Optimization of the Cleaning Protocol Review process
- Optimization of the Batch Review process
- Optimization of the QA Release process
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GlaxoSmithKline
- Specialist Quality & Compliance Clinical Laboratories
Marly-le-Roi
2013 - 2014
Context & mission:
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Before any manufacturing, each vaccine that is being developed has to be tested on voluntaries so that his efficiency can be evaluated. These assays, also called clinical assays, are performed by clinical laboratories, a unit belonging to the R&D department. Be the specialist quality & compliance for Global Vaccines Clinical Laboratories (GVCL) belonging to the Vaccines Discovery & Development (VDD) department and for ImmunoTherapeutics (ITx) department.
Role & responsibilities:
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- Ensure, optimize and maintain the compliance level of the quality systems with regulatory, GSK Corporate and GSK Bio standards in R&D Belgian sites
- Ensure audit activities, deviations management, CAPA follow up and protocol/report qualification/validation
- Prepare and manage quality trend analysis/quality review/QA monthly report
- Be responsible for coaching, training, development, motivation and evaluation of QA technicians through effective performance with KPI’s as instrument
- Reinforce partnership between Quality Assurance (QA)/Quality Operational (QO) and the Business
Results:
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- Participation to workshops to :
Implement SAP as a tool for deviations and CAPA management in R&D
Redefine followed KPI’s
- Trainer for GVCL/ITx regarding the implementation of SAP
- Active member of a green belt project
- Active member of the new QA strategy for ITx project
- QA representative in Troubleshooting Review Team (TRT)
- More than 300 deviations closed in 3 months
- Better partnership between QA/QO/Business
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Altran
- Consultant
Vélizy-Villacoublay
2013 - maintenant
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GlaxoSmithKline Biologicals
- Operational Quality Support
Marly-le-Roi
2010 - 2010
Context & mission:
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Processes and rooms from Logistic and Formulation units were under Operational and Performance Qualification.
The mission consisted in being the operational quality support in the two manufacturing teams.
Role & responsibilities:
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- Implement and follow KPI's in each team by creating a data sheet system allowing better management of their processes
- Ensure compliance between current Good Manufacturing Practices (cGMP) and activities (CIP, sterilization by autoclave and by filtration, leak test, integrity test of filters, weighing, pH-metry, conductivity, sampling for TOC and LAL analysis, air/particles sampling, cleaning of production area, filling of check-lists)
- Ensure the follow-up of deviations (opening, investigation and identification of the root cause, closing) and CAPA's
Results:
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- Each local's procedures were written in time
- Better understanding of activities by the staff
- Less errors by completing the batch record
- All initiated deviations closed in time
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GlaxoSmithKline Biologicals
- Supervisor Formulation
Marly-le-Roi
2009 - 2010
Context & mission:
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After the declaration of the pandemic status for H1N1 virus, whole pharmaceutical industries had to coordinate their activities launch large scale manufacturing so as to answer to the market needs.
The mission was to supervise the adjuvant manufacturing used for H1N1 vaccines with productivity and efficiency.
Role & responsibilities:
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- Supervise a team of 8 technicians and 4 operators (day to day, planning, training)
- Staff coaching for lean-manufacturing
- Implement KPI's within the team
- Ensure compliance between current Good Manufacturing Practices (cGMP) and daily activities (CIP, sterilization by filtration, leak test, weighing, pH-metry, conductivity, sampling for TOC and LAL analysis, air/particles sampling, cleaning of production area, filling of check-lists)
- Participate to the Operational and Performance Qualification of the equipment (Skid)
- Improve the material flow in the unit
- Update and review of documents used for daily activities (procedures, check-lists and batch record)
- Ensure the follow-up of deviations (opening, investigation and identification of the root cause, closing) and CAPA's
- Participation in FMEA
Results:
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- Equipement qualified and available in time to routine production
- Staff ready fo manufacturing activities in on month
- Better quality mind set for each member of the team
- No remark after the initial quality audit by authorities (ANSM - National Agency for Medicament Security)
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GlaxoSmithKline Biologicals
- Supervisor Bulk/Formulation/Filling
Marly-le-Roi
2008 - 2009
Context & mission:
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The logistic unit (non-terile and sterile) of the Viral bulk departement has to ensure the good receipt, the preparation (montage and sterilization), the storage and the delivery of materials to each viral unit with efficiency.
The mission consisted in being the support for the Low Virus Vaccines (LVV's) building by ensuring the logistic unit's supervision.
Role & responsibilities:
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- Supervise a team of 2 technicians and 23 operators (day to day, planning, training, recruitment)
- Implement lean-manufacturing within the team
- Implement KPI's within the team by creating a data sheet system allowing better management of the process
- Ensure compliance between current Good Manufacturing Practices (cGMP) and daily activities (CIP, sterilization by autoclave, leak test, integrity test of filter, conductivity, water/steam sampling for TOC and LAL analysis, air/particles sampling, cleaning of production area, filling of check-lists)
- Ensure writing and updating of logistic unit procedures
- Be the reference person for the area controlled parameters within the Bulk Stream department : Temperature / Pressure / Relative Humidity monitoring
- Study of trend analysis within the logistic unit and coordinate trend analysis for all other units.
- Plan and follow calibration and maintenance activities
- Plan and follow the revamping of an autoclave
Results :
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- Better productivity thanks to lean-manufacturing
- All loads delivered to each viral unit with efficiency
- Better participation of the staff regarding continuous improvement
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GlaxoSmithKline Biologicals
- Assistant scientist
Marly-le-Roi
2008 - 2008
Context & mission :
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When non-chemically defined, growth media used for microogranism are nutritionally fluctuant and contain, for some of them, animal source nutrients. Manufacturing and/or consumer security can be affected because of the variant yield and transmissible spongiform encephalopathy.
My mission was to formulate and optimize a chemically defined medium.
Role & responsabilities :
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- Evaluate the feasibility of the project
- Analyze, qualitatively and quantitatively, the non-chemically defined medium that was already used for manufacturing activities
- Analyze nutritionals needs for the studied strain
- Create an upstream processing in a Biosafety Level 3 laboratory
- Find a vegetable source nutrient to replace any animal one contained in the non-chemically defined medium
- Formulate different chemically defined media
- Assess the ability of the strain to grow on them through experimental protocols (use of spectrophotometer, use of centrifuge, GRAM coloration, microplate)
- Optimize the growing parameters
- Report advancement of the project to the staff
Results :
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Potential candidates were found regarding the replacement of the animal source nutrient by a vegetable one
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Laboratoire de Mycologie/Phytopathologie/Environnement
- Stagiaire assistant ingénieur R&D
2007 - 2007
- Etude du potentiel de biomolécules lipopeptidiques comme agents de lutte contre deux maladies du blé ;
- Réalisation de recherches bibliographiques ;
- Evaluation expérimentale et statistique des activités antifongiques et surfactantes des biomolécules.
