Sara Gerault - Renaux
Regulatory Affairs Pharmacist at LINDE FRANCE- Claim this Profile
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Bio
Experience
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LINDE FRANCE
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France
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Chemical Manufacturing
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1 - 100 Employee
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Regulatory Affairs Pharmacist
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Jul 2016 - Present
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Pharmacist / Compliance Specialist
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Sep 2012 - Jun 2016
Manage GMP/cGMP compliance projects and qualification / validation projects in pharmaceutical industries:- Update and implementation of QA system (deviation, CAPA, change control, APR);- Analyze and interpret fabrication and quality control results for batch release;- Issue validation protocols, Installation Qualification, Operation Qualification, Performance Qualification (IQs, OQs, and PQs), for equipment and systems;- Write program and evaluation form for training of production personnel
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Linde Gas
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Germany
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Chemical Manufacturing
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Pharmacist / Qualified Person
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Jan 2012 - Aug 2012
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Qualified Person
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Jul 2010 - Sep 2011
QP for solid form - cGMP : Batch release, deviation and CAPA management QP for solid form - cGMP : Batch release, deviation and CAPA management
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Geodis
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France
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Transportation, Logistics, Supply Chain and Storage
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700 & Above Employee
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Pharmacist
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Feb 2010 - Mar 2010
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3M Health Care
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Hospitals and Health Care
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1 - 100 Employee
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Qualified Person
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Oct 2008 - Oct 2009
QP for oral, transdermic and inhalator form - US and EU GMPBatch release, change control, deviation and CAPA managementAnnual Product Quality Review redactionAQ Training QP for oral, transdermic and inhalator form - US and EU GMPBatch release, change control, deviation and CAPA managementAnnual Product Quality Review redactionAQ Training
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Pharmacist - Internship
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Mar 2007 - Oct 2007
Production DepartmentRedaction of program and documents for training of production staff (granulation and coating of tablets) Production DepartmentRedaction of program and documents for training of production staff (granulation and coating of tablets)
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Chiesi Group
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Italy
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Pharmaceutical Manufacturing
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700 & Above Employee
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Pharmacist - Internship
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Jul 2006 - Aug 2006
Packaging DepartmentRedaction of master batch record Packaging DepartmentRedaction of master batch record
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Education
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2006 - 2007
Université de Toulouse - Paul Sabatier
Master's degree, Pharmaceutical Industrie - Production, Quality and Control of Drug Products -
2000 - 2007
Université François Rabelais de Tours
Doctor of Pharmacy (Pharm.D.), Pharmaceutical Industrie - Quality and Production
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