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SysComm Project Management Ltd
- Senior CQV Lead
2017 - maintenant
SysComm is a project life cycle management company that helps clients achieve their business goals in the pharmaceutical and medical device world.
Relax. Your journey just got easier.
You need people who can work with you in an open, honest way. People who can be counted on. Who are on your side, no matter what.
“SysComm exists, to get our clients through their world. We achieve this by being the best at what we do, simplifying the complex and collaborating deeply with our client’s team to meet their goals.”
SysComm is established as a leader in the Project Management of Life Science capital construction and equipment procurement.
Life Cycle Management (LCM) involves the complete understanding of your requirements, verifying them and managing them through the complete project life cycle – up to the end of your successful audit.
SysComm can pick up a C&Q programme at any stage of the Project’s lifecycle and deliver it to a successful completion for our client.
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Biogen Idec
- Principal Engineer Assembly Labeling and Packaging Consultant for Oxford International
Nanterre Cedex
2016 - 2017
For the Global Engineering department, manage the technical aspects of the ALP equipment and production rooms. Key deliverables include Serialization, Engineering flow diagrams, Process flow diagrams, validation plans, protocols and reports, Gap analysis, Risk assessment, Financial tables which will contribute the data required for the project management. Based on the product all duties were conducted in compliance with current Good Manufacturing Practice (GMP) and regulatory requirements as defined by applicable standards i.e. 21 CFR 11/210/211.
Serialization, packaging/distribution process improvements, engineering, qualification and Validation. Risk analysis, PFMEA, Due diligence report, TOR Management.
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Teoxane SA
- QA Validation Manager
Paris
2015 - 2015
Define and Set strategies for all validation and qualification activities associated with the introduction of products to FDA. Key deliverables include validation plans, protocols and reports which will contribute the data required for regulatory submissions. Based on the product to be launched all duties were conducted in compliance with current Good Manufacturing Practice (GMP) and regulatory requirements as defined by applicable standards i.e. ISO13485, 21 CFR 600 and 820. Preparation of documentations for submission to the F.D.A. With QA department, realization of supplier’s audits (2 done in Italia and Germany).
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Quotient
- MosaiQ Validation Manager
2014 - 2014
Define and Set strategies for all validation and qualification activities associated with the introduction of the new product through design/development, technical transfer, manufacturing and licensure.
Acting as the primary interface between The Validation Department, Assay/Product Development team and all manufacturing partners, I am ensuring that during all phases of product development focus is given to delivery of a robust validation plan ensuring success at each of the identified phases.
Key deliverables include validation plans, protocols and reports which will contribute the data required for regulatory submissions. Based on the product to be launched all duties will be conducted in compliance with current Good Manufacturing Practice (GMP) and regulatory requirements as defined by applicable standards i.e. ISO13485, 21 CFR 600 and 820.
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Aston Life Sciences
- Senior Consultant
Lausanne
2012 - 2013
Qualification and Validation of all equipments and processes to put in conformity to the regulations. Preparation of documentations for submission to the F.D.A. Engineering design and drawing of the first factory for the client with the follow up of the new line installation (area, HVAC, black piping, clean piping, steam, purified water, …)
Work closely with New Product team, quality to establish and document the master validation plan in conformance with the system design specification. Plans, coordinates and executes design verification testing to directly support the master validation plan. Participates with the New Product team to establish and review the design or process FMEA. Routinely provides assurance guidance and direction to engineers.
Work closely with the QA and Regulatory teams to develop, update and implement the new QMS. Realization of supplier’s audits (3 done Netherlands, Germany and Italia).
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Zimmer Surgical S.A.
- Process Engineer - Validation Senior Consultant For Oxford
2012 - 2012
Process and validation evaluation, update of the working area, study of global and local SOPs, update of working method with the team in place and update of all concerned SOPs and batch record. Qualification and Validation of all equipments and processes to put in conformity to the regulations. Preparation of documentations for submission to the F.D.A.
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CAF-DCF
- Cleaning Validation Coordinator
2011 - 2011
Coordination, gestion des différentes sociétés de consulting en corrélation avec les différents départements concernés. Rédaction d'un rapport complet de la situation et mise en place des plans d'action et CAPA pour la remise à niveau du Cleaning. Mise en place de la nouvelle strategie Cleaning en routine. Formations données sur le Cleaning et la Validation. Défense des documents lors de l'audit FDA.
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VS Consult Services sprl / Avertim / GSKBio
- Cold Chain
2010 - 2010
Mise en place de la stratégie Cold Chain pour les magasins GSK Bio et support au développement dans les autres unités et les autres sites. Mise à niveau des validations, du suivi, des flux, des conceptions, ... pour assurer une maîtrise complète de la Cold Chain depuis la production jusqu'aux clients finaux.
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GSKbio
- For Avertim Flu pandemic manufacturing strategy technical and validation project director
2009 - 2010
For the pandemic flu manufacturing, the respect of the strategy, the uniformization of all the validation tests and philosophie, ... for all sites and subcontractors everywhere in the world.
Coordination between all sites for adjuvant and antigen production. Follow up of production transfert and validation realization with PTT (Product Transfer Team) and GTS (Global Technical Services). Follow up of technical problems with GTS and local technical services.
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VS Consult Services sprl
- Senior Trainer
2009 - 2012
Training in Engineering, Validation, Qualification, Audit, cGMP
Training – Introduction to "Pharma"
This training will outline the operation of pharmaceutical company, explain to you the key departments and their implications, the different regulations they have to comply with, the specific way to work in this environment, … This is a one day training session for groups of 6 to 13 people. This training can be given in your own premises.
Training – Introduction to "Validation"
This training will simply explain Who, When, Where What Why, & How you perform qualification/validation ; the different current regulations and how to interpret them. This is a one day training session for groups of 6 to 13 people. This training can be given in your own premises.
Training in validation
You are a project manager, validation manager, consultants in pharmaceutical field or you simply want to improve yourself in the interpretation of regulations, in the writing of protocols, in the documentation of your qualification/validation files, in compliance with the regulations (cGMP, GMP, ISO, ...). We offer you a training developped from the experience of presenting Qualification/Validation files at several FDA audits. This training can be adapted to your specific needs and will help you apply the regulations to your own documents. This training is given in 5 days in 2 sessions (3 days + 2 days) for groups of 6 to 13 people. This training can only take place in our own premises.
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VS Consult Services
- Senior Auditor - FDA Specialist
2006 - 2012
perform preparation audits before regulations audits.
∝ Preparation Audit for European pharmacopeia and FDA Regulation
• Audits : Medtronics (Fourmies FR), Diagast (Loos FR), GSK sites and subcontractors (France, Germany, USA, Canada, Italia, …), Synthexim (Calais FR), Besins Manufacturing (Drogenbos BE) and (Montrouge FR), Catalent (Brussels BE), …
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VS Consult Services sprl
- Senior Consultant in QA-Validation and engineering
2001 - 2011
Commissionning, Security and environment and Q.A. used in pharmaceutical’s industries .
Study and development of area and equipment with conception of documents for approvals ISO 9000, European rules and FDA.
Commissionning of area and equipment with conception of documents for approvals ISO 9000, European rules and FDA.
Qualification of area and equipment with conception of documents for approvals ISO 9000, European rules and FDA.
Security and study of environment impact of production with conception of documents for approvals.
GMP, management of quality, customer’s audit … with conception of documents for approvals ISO 9000, European rules and FDA.
Preparation of Regulation audit from European pharmacopeia and FDA..
Lessons for conception, writing, filling of Validation, Qualification, Commissionning protocols. used in pharmaceutical’s industries .
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VS Consult Services sprl
- General Manager
2001 - 2012
VS Consult Services sprl is a small company which employs only experienced consultants. These experts in engineering, validation and QA will provide you with quality support & flexibility, … in compliance with the current regulations.
Specialised in project management in both engineering and validation, VS Consult Services provide specific advice in the design and the improvement of production areas, premises & equipment (OEE) ; improvement of material and personel flows in compliance with the régulations (cGMP, GMP, ISO, ...), and an experienced support for commissionning, qualification, process validation, cleaning validation, computerised system validation & cold chain managment, ...
VS Consult services sprl offers you its expertises in Quality Assurance. Our team of experienced consultants will provide the most relevant support and solutions in the management of your quality systems adapted to your needs. Among other services we offer our help and assistance in :
➢ Execution of external companies audits (supplier, subcontractor,…) or internal audits
➢ Preparation for and follow-up of regulatory audits (Customer, MOH,…)
➢ Writing and updating of quality documents
➢ Writing of technical and quality agreements with your customers and your suppliers
➢ Updating and implementetion of different QA processes (change control, CAPA, deviation, complaints, …)
➢ Implementation of follow-up and monitoring tools for your different quality processes
➢ Implementation and follow-up of continuous quality improvement plan
Our mission is to bring relevant solutions to you adapted to your needs. Our motto is flexibility, quality, availability and adaptability. Everyday more customer trust us for the management of their engineering projects, their validation projects and their quality systems (QA).
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UCB-Bioproducts
- Head od engineering Validation
1994 - 2004
➢ Development and Validation of W.F.I. Analysis, UCB, Bruxelles, 1994.
➢ Development and Validation of Cleaning Validation, UCB, Bruxelles, 1995.
➢ Development and Qualification of Equipments (Autoclaves, Lyophilisators, H.V.A.C., Laminar Flow, Insulators, Cooling Chambers, Controlled Humidity and Temperature Chambers, Laboratories (HPLC, GC, …) Water Installations, reactors, dryers, purification lines, …) and Instruments Calibration, UCB, Braine-l’Alleud, de 1994 à 2005.
Engineering, Installation, protocols’ writing of commissioning, validation (project management from engineering to validation) … and procedures of use and maintenance, and making of tests and signature of certificate before production, Cleaning Validation and process Validation.
➢ Development, Setup and Management of Cold Chain (Storage, Transfers, Transports, …)
➢ Development, Study and revamping of QC Laboratories (Cold rooms, Bench, analytical equipments, material and personnel’s flows, …).
Presentation of Engineering, Qualification, Validation, Calibration during 6 FDA audits
