Benoit Germain Email and Phone Number
Benoit Germain work email
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Benoit Germain personal email
Benoit Germain is a Senior Chromeleon Consultant chez Thermo Fisher Scientific at Thermo Fisher Scientific. He possess expertise in ansm, secteur pharmaceutique, biotechnologie, hplc, validation and 2 more skills.
Thermo Fisher Scientific
View- Website:
- thermofisher.com
- Employees:
- 53105
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Senior Chromeleon ConsultantThermo Fisher Scientific Oct 2018 - PresentVillebon (France, 91)-Manage projects and lead technical delivery teams within projects.-Deliver technical work relating to Chromeleon CDS.-Deliver high quality consultancy relating to Chromeleon CDS, which may include software installation, validation and configuring laboratory instruments for data acquisition.-Deliver successful performance relative to defined performance metrics.-Work onsite, face to face with customers at all levels.-Provide technical expertise in all areas of Chromatography Data Systems.
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Analytical Project ManagerBiogaran Mar 2017 - Oct 2018ColombesContext: Management of drug products in Biogaran Analytical Support (according to GMP)-Performing and reviewing of Analytical Method Transf/Validation according to ICHQ2/ICHQ9, including data processing with statistical tools, and Risk Assess.-Managing of Analytical Deviation (OOS/OOT and OOE) and CAPA Implementation, -Creating/ updating of Internal Procedures and Marketing Authorization Dossier -Coordination and interpretation of stability studies according to ICH Q1 -
Analytical Project Manager For BiogaranCvo-Europe Jul 2016 - Mar 2017Région De Paris, France-Performing and reviewing of Analytical Method Transf/Validation according to ICHQ2/ICHQ9, including data processing with statistical tools, and Risk Assess.-Managing of Analytical Deviation (OOS/OOT and OOE) and CAPA Implementation, -Creating/ updating of Internal Procedures and Marketing Authorization Dossier -Coordination and interpretation of stability studies according to ICH Q1 -
Contractant As Validation/ Qa Project Manager For ServierCvo-Europe Mar 2016 - Aug 2016Région De Paris, FranceEDM Data Migration Validation :-Realize user's tests-Write validation plan and FMEA risk assessment -Write IQ OQ and QP protocols -Write migration tests -Perfom OQ and PQ-Manage deviation-Write validation report
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Contractant As Validation Project Manager For SanofiCvo-Europe Apr 2016 - Jul 2016Région De Paris, FranceContext: Biotech site (GMP and cGMP) :- Write risk assessment and the related protocols based on ICH Q9-Execute IQ and OQ tests (balances, reactor,....) -Deviation Management-Write validation reports
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Contractant As Validation Project Manager For Octapharma :Cvo-Europe Mar 2014 - Feb 2016Région De Strasbourg, FranceContexte : Biotechnilogic facility, QC. Preparation for PAI by FDA purpose-Write and update VMP-Implemente validation strategy based on complexity of the different system and their related criticity -Write user and administration manuals -Implemente administration process in a data integrity context -Perform periodic review of systems-Fully Validate lab system ( instrument and software) based on risk assessment-Write URS, DQ, validation plan, risk analysis, IQ OQ PQ -AdministratE LAB Systems-Write risk assessment based on system complexity (FMEA, maintenance,...)
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Contractant As Validation Project Manager For Octapharma : Chromeleon Cds In Network InstallationCvo-Europe Jun 2015 - Oct 2015Région De Strasbourg, FranceContexte: Biotechnilogic facility, QC lab. Chromeleon CDS (Thermo) -Support to project manager (meeting with vendors, management of validation,...) - Write URS, review of vendor proposal, write QD - Manage FMEA risk assessment meetings with users, IT team and quality staff - Write Validation Plan and risk assessment - Write IQ OQ and QP -Supervise supplier installation -Supervise or execute tests -Coordinate user and administrator training-Supervise analytical methods in CDS -Deviation and CAPA management
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Contractant As Validation Project Manager For NovartisCvo-Europe Dec 2012 - Jan 2014Région De Basel, SuisseContext: Biotech facility (GMP and cGMP)-Write and update VMP-Update qualification protocol according to japanese, american and european pharmacopeia.-Implemente validation strategy based on complexity of the different system and their related criticity -Write user and administration manuals -Write FMEA risk assessment -Write URS, IQ OQ PQ for an initial qualification -Update balance documentation according to the new chapter <41> from American Pharmacopeia
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Team ManagerGroupe Carso Oct 2011 - Dec 2012Région De Strasbourg, FranceContext: Technical Supervisor in a food sub contractor lab certified Cofrac (nutritional values , contamination, allegations,…)-Manage a night team of 6 technicians ,-Check and interpret chemical analysis results, -Manage consumer complaints,-Manage deviations-Know different regulatory texts (Lamy-Dehove, normes ISO, Code des usages…),o Know various technics and methods (nutritional, contamination, metrology,...),
Benoit Germain Skills
Benoit Germain Education Details
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Chimie Analytique -
Industries Chimique Et Pharmaceutique
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Chimie
Frequently Asked Questions about Benoit Germain
What company does Benoit Germain work for?
Benoit Germain works for Thermo Fisher Scientific
What is Benoit Germain's role at the current company?
Benoit Germain's current role is Senior Chromeleon Consultant chez Thermo Fisher Scientific.
What is Benoit Germain's email address?
Benoit Germain's email address is be****@****her.com
What schools did Benoit Germain attend?
Benoit Germain attended Université De Bourgogne, Université De Bourgogne, Université De Strasbourg.
What skills is Benoit Germain known for?
Benoit Germain has skills like Ansm, Secteur Pharmaceutique, Biotechnologie, Hplc, Validation, Gmp, Quality Assurance.
Who are Benoit Germain's colleagues?
Benoit Germain's colleagues are Simone Barthlomé, Jean Delong, Eda Küçükakdoğan, Liliana Suárez, Zach Cornu, Nur Abdul Samad, Shirley Wong.
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Benoit Germain
Sous-Directeur Du Dialogue Social, Des Politiques Sociales Et Des Conditions De Travail, Drh Des Ministères SociauxParis -
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