Experience

Baccinex

• Switzerland
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• QA CSV Specialist

  • Feb 2022 - Present



Accord Healthcare

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Validation Officer

  • Sep 2018 - Oct 2021

  Leading validation ProjectsEquipment Qualification: packaging, compression, sterile linesWriting validation documentation, tests supervision Facilities/utilities validationCSVProcess validation: effervescent tablets Leading validation ProjectsEquipment Qualification: packaging, compression, sterile linesWriting validation documentation, tests supervision Facilities/utilities validationCSVProcess validation: effervescent tablets



CVO-EUROPE

• France
• Business Consulting and Services
• 300 - 400 Employee

• Qualification/Validation Consultant

  • Jun 2013 - Jun 2018

  Several missions for various clients : Merck, Baxter, Novartis, Johnson&Johnson ... - Computer System Validation (CSV)- Qualification of Production Equipment (Biotechnology)- CIP Validation (Cleaning In Place)- Writing Validation documents : Validation plan, protocols/reports, URS, risks analysis,specifications, traceability matrix, procedures- Execution and coordination of tests (FAT/SAT/Commissioning/IQ/OQ/PQ)- Quality review of validation phases - Management of deviations and gaps- Improvement of validation documents and processes- Coordination and training of users and suppliers- Project management- Data Integrity



LEO Pharma A/S

• Italy
• Advertising Services

• CSV Engineer

  • Dec 2012 - Jun 2013

  Implementation and validation of a DMS (Document Management System)• Writing qualification documents: validation plan, specifications, protocols ( IQ/OQ/PQ), reports, operating procedures• Tests execution• Management of non conformities• User training and support• Improvement and administration of the system• Supplier management Implementation and validation of a DMS (Document Management System)• Writing qualification documents: validation plan, specifications, protocols ( IQ/OQ/PQ), reports, operating procedures• Tests execution• Management of non conformities• User training and support• Improvement and administration of the system• Supplier management



Sanofi Pasteur

• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Qualification/Validation Trainee

  • Feb 2012 - Aug 2012

  Qualification of laboratory equipment and associated computerized systemsRedaction of qualification documentation : user specifications (URS ), qualification protocols (IQ/OQ) Traceability MatrixTests execution (IQ/OQ) and writing of reports Transfer of equipmentWriting quality documents: procedures, instructions Qualification of laboratory equipment and associated computerized systemsRedaction of qualification documentation : user specifications (URS ), qualification protocols (IQ/OQ) Traceability MatrixTests execution (IQ/OQ) and writing of reports Transfer of equipmentWriting quality documents: procedures, instructions