Carole FERNANDEZ

Head Of QA - GMP faciity (Toulouse -Actisud) and R&D laboratories (Labège) at GTP Bioways
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Contact Information
us****@****om
(386) 825-5501
Location
Toulouse, Occitanie, France, FR
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Aurélie Lorvellec

J'ai apprécié travailler avec Carole. Carole m'a beaucoup appris dans la mise en place de l'ISO 22000 et le suivi du système de management de la qualité. Le dynamisme dont elle fait preuve est communicatif. Carole sait motiver son équipe.

Audrey Dessouroux

Je recommande Carole George pour son savoir faire et sa ténacité. Ayant travaillé quelques années sur le développement de matières premières à usage pharmaceutique j'ai pu apprécié sa rigueur dans le travail (aboutissement des dossiers qualité, mise en place des procédures) et son relationnel.

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Credentials

  • Conduite du changement (4jours)
    Veronique Palmieri
    Dec, 2018
    - Sep, 2024
  • Annexe1 des GMP & GMP des MTI (Eudralex vol 4 part IV)
    A3P Association
    Mar, 2018
    - Sep, 2024
  • MBTI (3jours)
    Veronique Palmieri
    Sep, 2013
    - Sep, 2024
  • Formation aux allergenes
    SYNADIET - Syndicat national des compléments alimentaires
    Jan, 2011
    - Sep, 2024
  • Management situationnel - 10 jours
    IDAE Consulting
    Jan, 2010
    - Sep, 2024
  • Auditeur qualite (audits internes et fournisseurs)
    CETEN APAVE INTERNATIONAL
    Jan, 2009
    - Sep, 2024

Experience

  • GTP Bioways
    • France
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Head Of QA - GMP faciity (Toulouse -Actisud) and R&D laboratories (Labège)
      • Jan 2022 - Oct 2023

      Implementation of a GMP compliant (vs EUDRALEX vol4 part II) QMS in GTP Technology Compagny, part of GTP Bioways Group - ACTISUD facilities (Toulouse). QA management in our R&D laboratories in Labege (31). Implementation of a GMP compliant (vs EUDRALEX vol4 part II) QMS in GTP Technology Compagny, part of GTP Bioways Group - ACTISUD facilities (Toulouse). QA management in our R&D laboratories in Labege (31).

  • Flash Therapeutics
    • France
    • Biotechnology Research
    • 1 - 100 Employee
    • Quality Manager, QA & QC, regulation and HSE
      • May 2018 - Dec 2021

      GMP implementation management in compliance with ATMP requirements (EUDRALEX Vol 4 Part IV). GMP implementation of our QMS in order to produce aseptically lentiviral vectors used as Starting Material in gene and cell therapies clinical trials (I & II phase) in Meary Institute at St Louis hospital (Paris X). Audit by a US client vs FDA requirements : no major nor critical findings, 11 minor findings. Gap analysis towards FDA requirements on raw material specifications & QC plan : no… Show more GMP implementation management in compliance with ATMP requirements (EUDRALEX Vol 4 Part IV). GMP implementation of our QMS in order to produce aseptically lentiviral vectors used as Starting Material in gene and cell therapies clinical trials (I & II phase) in Meary Institute at St Louis hospital (Paris X). Audit by a US client vs FDA requirements : no major nor critical findings, 11 minor findings. Gap analysis towards FDA requirements on raw material specifications & QC plan : no criticial findings ; only optimization of the Qc plan. Show less GMP implementation management in compliance with ATMP requirements (EUDRALEX Vol 4 Part IV). GMP implementation of our QMS in order to produce aseptically lentiviral vectors used as Starting Material in gene and cell therapies clinical trials (I & II phase) in Meary Institute at St Louis hospital (Paris X). Audit by a US client vs FDA requirements : no major nor critical findings, 11 minor findings. Gap analysis towards FDA requirements on raw material specifications & QC plan : no… Show more GMP implementation management in compliance with ATMP requirements (EUDRALEX Vol 4 Part IV). GMP implementation of our QMS in order to produce aseptically lentiviral vectors used as Starting Material in gene and cell therapies clinical trials (I & II phase) in Meary Institute at St Louis hospital (Paris X). Audit by a US client vs FDA requirements : no major nor critical findings, 11 minor findings. Gap analysis towards FDA requirements on raw material specifications & QC plan : no criticial findings ; only optimization of the Qc plan. Show less

  • Vectalys By Flash Therapeutics
    • France
    • Biotechnology Research
    • 1 - 100 Employee
    • Quality Manager - QA & QC, HSE
      • Jul 2012 - May 2018

      Private biotech company expert in gene delivery, providing full services from expression system design to animal model creation. Supervising the Quality Hygiene Security and Environnment Department : Quality Control and Quality Assurance, Hygiene In BSL2 and BSL1, Security and protection of Environnment (GMO rejections, waste,...). Building the Quality Management System : SOPs, CAPAs, OOS, change control, audits, staff training for R&D grade activities. Quality… Show more Private biotech company expert in gene delivery, providing full services from expression system design to animal model creation. Supervising the Quality Hygiene Security and Environnment Department : Quality Control and Quality Assurance, Hygiene In BSL2 and BSL1, Security and protection of Environnment (GMO rejections, waste,...). Building the Quality Management System : SOPs, CAPAs, OOS, change control, audits, staff training for R&D grade activities. Quality improvement : CAPAs management, quality indicators review, managing review, Lean management (Value Stream Mapping),... Improving quality system in order to release batches. Setting supply chain based on Lean Manufacturing principles in order to deliver new products (highly purified and concentrated lentiviral vectors particles for reprogramming human somatic cells) on the international market. Security : hazards analysis and following of personal exposure to Chemicals. Show less Private biotech company expert in gene delivery, providing full services from expression system design to animal model creation. Supervising the Quality Hygiene Security and Environnment Department : Quality Control and Quality Assurance, Hygiene In BSL2 and BSL1, Security and protection of Environnment (GMO rejections, waste,...). Building the Quality Management System : SOPs, CAPAs, OOS, change control, audits, staff training for R&D grade activities. Quality… Show more Private biotech company expert in gene delivery, providing full services from expression system design to animal model creation. Supervising the Quality Hygiene Security and Environnment Department : Quality Control and Quality Assurance, Hygiene In BSL2 and BSL1, Security and protection of Environnment (GMO rejections, waste,...). Building the Quality Management System : SOPs, CAPAs, OOS, change control, audits, staff training for R&D grade activities. Quality improvement : CAPAs management, quality indicators review, managing review, Lean management (Value Stream Mapping),... Improving quality system in order to release batches. Setting supply chain based on Lean Manufacturing principles in order to deliver new products (highly purified and concentrated lentiviral vectors particles for reprogramming human somatic cells) on the international market. Security : hazards analysis and following of personal exposure to Chemicals. Show less

  • PiLeJe Industrie
    • France
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Quality Department Manager - QA & QC
      • Jan 2009 - Jun 2012

      Groupe 3i nature Herbal extraction and enzymatic hydrolysis production for food supplements and starting material for herbal drugs (officinal preparation). Building the Assurance Quality System in compliance with the ISO 9001, ECOCERT & COSMEBIO ECOCERT Greenlife certification, ISO 22000 - HACCP and GMP (EUDRALEX vol4 part II). Supervising of the quality department (Quality Assurance and Quality Control). Setting up CAPAs for continuous improvement. Leading the quality… Show more Groupe 3i nature Herbal extraction and enzymatic hydrolysis production for food supplements and starting material for herbal drugs (officinal preparation). Building the Assurance Quality System in compliance with the ISO 9001, ECOCERT & COSMEBIO ECOCERT Greenlife certification, ISO 22000 - HACCP and GMP (EUDRALEX vol4 part II). Supervising of the quality department (Quality Assurance and Quality Control). Setting up CAPAs for continuous improvement. Leading the quality system review. Staff Training : quality, audit, hygiene,.. Taking part in the ERP and Lean Management deployment (Value Stream Mapping). Permanent member of the management council (COPIL). Show less Groupe 3i nature Herbal extraction and enzymatic hydrolysis production for food supplements and starting material for herbal drugs (officinal preparation). Building the Assurance Quality System in compliance with the ISO 9001, ECOCERT & COSMEBIO ECOCERT Greenlife certification, ISO 22000 - HACCP and GMP (EUDRALEX vol4 part II). Supervising of the quality department (Quality Assurance and Quality Control). Setting up CAPAs for continuous improvement. Leading the quality… Show more Groupe 3i nature Herbal extraction and enzymatic hydrolysis production for food supplements and starting material for herbal drugs (officinal preparation). Building the Assurance Quality System in compliance with the ISO 9001, ECOCERT & COSMEBIO ECOCERT Greenlife certification, ISO 22000 - HACCP and GMP (EUDRALEX vol4 part II). Supervising of the quality department (Quality Assurance and Quality Control). Setting up CAPAs for continuous improvement. Leading the quality system review. Staff Training : quality, audit, hygiene,.. Taking part in the ERP and Lean Management deployment (Value Stream Mapping). Permanent member of the management council (COPIL). Show less

  • Pileje
    • France
    • Pharmaceutical Manufacturing
    • 300 - 400 Employee
    • Quality manager -QA & QC
      • Jun 2004 - Jun 2012

      Groupe Larena Setting up the Good Manufacturing Practice (GMP) in the factory : Quality Control at each step of the process, log books, Change Control, Out Of Specification analytical results, validation technology, releasing production batches, controling non conforming products, following-up clients requests and writting suppliers requirements. Staff training in quality, audit and hygiene. -> Certificate of GMP compliance obtained since 2005. Supervising of the quality… Show more Groupe Larena Setting up the Good Manufacturing Practice (GMP) in the factory : Quality Control at each step of the process, log books, Change Control, Out Of Specification analytical results, validation technology, releasing production batches, controling non conforming products, following-up clients requests and writting suppliers requirements. Staff training in quality, audit and hygiene. -> Certificate of GMP compliance obtained since 2005. Supervising of the quality department (Quality Assurance and Quality Control). Leading factory auto-inspections, internal audits and suppliers audits. Organizing staff training : job descriptions,SOPs, skills management, training plan and financial aspects: CIF, DIF,.... Permanent member of the management council. Show less Groupe Larena Setting up the Good Manufacturing Practice (GMP) in the factory : Quality Control at each step of the process, log books, Change Control, Out Of Specification analytical results, validation technology, releasing production batches, controling non conforming products, following-up clients requests and writting suppliers requirements. Staff training in quality, audit and hygiene. -> Certificate of GMP compliance obtained since 2005. Supervising of the quality… Show more Groupe Larena Setting up the Good Manufacturing Practice (GMP) in the factory : Quality Control at each step of the process, log books, Change Control, Out Of Specification analytical results, validation technology, releasing production batches, controling non conforming products, following-up clients requests and writting suppliers requirements. Staff training in quality, audit and hygiene. -> Certificate of GMP compliance obtained since 2005. Supervising of the quality department (Quality Assurance and Quality Control). Leading factory auto-inspections, internal audits and suppliers audits. Organizing staff training : job descriptions,SOPs, skills management, training plan and financial aspects: CIF, DIF,.... Permanent member of the management council. Show less

  • Lallemand
    • Canada
    • Food and Beverage Manufacturing
    • 700 & Above Employee
    • Quality Assurance manager
      • Apr 2003 - Dec 2003

      Food and pharmaceutical bacteria manufacturing facility. Change managing from the Assurance Quality System based on the ISO 9001 v 94 standard to the Quality Management System based on the ISO 9001 v 2000 standard. -> ISO 9001 certificate obtained at the end of the work period. Wrote all the quality documents (ie processus description) necessary to obtain the certification. Inform all manufacturing staff about the changes due to the ISO 9001 v 2000… Show more Food and pharmaceutical bacteria manufacturing facility. Change managing from the Assurance Quality System based on the ISO 9001 v 94 standard to the Quality Management System based on the ISO 9001 v 2000 standard. -> ISO 9001 certificate obtained at the end of the work period. Wrote all the quality documents (ie processus description) necessary to obtain the certification. Inform all manufacturing staff about the changes due to the ISO 9001 v 2000 standard. Intern supervising to set up cleaning documents and to train and evaluate production staff. Show less Food and pharmaceutical bacteria manufacturing facility. Change managing from the Assurance Quality System based on the ISO 9001 v 94 standard to the Quality Management System based on the ISO 9001 v 2000 standard. -> ISO 9001 certificate obtained at the end of the work period. Wrote all the quality documents (ie processus description) necessary to obtain the certification. Inform all manufacturing staff about the changes due to the ISO 9001 v 2000… Show more Food and pharmaceutical bacteria manufacturing facility. Change managing from the Assurance Quality System based on the ISO 9001 v 94 standard to the Quality Management System based on the ISO 9001 v 2000 standard. -> ISO 9001 certificate obtained at the end of the work period. Wrote all the quality documents (ie processus description) necessary to obtain the certification. Inform all manufacturing staff about the changes due to the ISO 9001 v 2000 standard. Intern supervising to set up cleaning documents and to train and evaluate production staff. Show less

  • Unilever
    • United Kingdom
    • Manufacturing
    • 700 & Above Employee
    • Quality Assurance Intern
      • Feb 2002 - Sep 2002

      Puget Olive Oil conditioning facility. Creating a Quality control indicator in order to minimize defects on olive oil bottles. Writting Quality / Security / Environment documents in order to inform temporary staff about the riks and the rules to their posts. Taking part in quality facility ISO 9001 certification : quality book, audit, HACCP, training to manufacturing staff, Quality Management System. Puget Olive Oil conditioning facility. Creating a Quality control indicator in order to minimize defects on olive oil bottles. Writting Quality / Security / Environment documents in order to inform temporary staff about the riks and the rules to their posts. Taking part in quality facility ISO 9001 certification : quality book, audit, HACCP, training to manufacturing staff, Quality Management System.

  • CRITT Bio-Industrie
    • France
    • Biotechnology Research
    • 1 - 100 Employee
    • Engineer Internship
      • Feb 2001 - Jun 2001

      R&D- Bacterial cryptic growing based on ultrasounds induced lysis. R&D- Bacterial cryptic growing based on ultrasounds induced lysis.

  • Pierre Fabre Group
    • France
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Student Internship
      • 1999 - 1999

      R&D- Q10 coenzyme extraction. R&D- Q10 coenzyme extraction.

Education

  • Institut national des Sciences appliquées de Toulouse
    Master's degree, Biochemical engineering
    1996 - 2001
  • Toulouse Pharmaceutical University
    Pharmaceutical regulation
    2011 - 2011
  • ISAA (Superior Institue for Food Processing)
    Food Industry
    2001 - 2002

Community

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