Marine SUCHER

Quality Specialist at Biom'up
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Contact Information
us****@****om
(386) 825-5501
Location
Greater Lyon Area, FR
Languages
  • Français Native or bilingual proficiency
  • Anglais Professional working proficiency
  • Allemand Elementary proficiency
Skills

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Credentials

  • Développer la résilience
    LinkedIn
    Feb, 2022
    - Oct, 2024
  • Yellow Belt Lean Six Sigma
    ACS PERFORMANCE FORMATION CONSEIL
    Oct, 2020
    - Oct, 2024

Experience

  • Biom'up
    • France
    • Biotechnology Research
    • 1 - 100 Employee
    • Quality Specialist
      • Sep 2020 - Present

      - Non-conformity & deviation system manager (process improvement, documentation and KPIs).- Non-conformity & deviation investigator.- Quality Mindset deployment in operationnal services through implementation of a field audit process and continuous improvement projects (Lean Management & Six Sigma - Yellow-Belt certification).- CAPA investigator.- Supplier Quality Assurance support : management of suppliers/subcontractors (SCAR, audit, process improvement, intern QMS deployment).- Supplier lead auditor.NF EN ISO13485:2016, EU MDR 2017/745, Directive 93/42/CEE, GMP 21CFR part 820 : inspection participation (frontroom & backroom).

    • Quality Specialist
      • May 2018 - Sep 2020

      - Change Control system manager :.Improvement of the change control process : implementation of committee and deployment of associated documentation..QA referent for industrialization (e.g. scale-up phases), production (e.g. equipment duplication) and QC (e.g. analytical method validation) project.- Non-conformity & deviation investigator.- CAPA investigator.- Supplier Quality Assurance support : management of suppliers/subcontractors (SCAR, audit, process improvement, intern QMS deployment).- Supplier lead auditor.NF EN ISO13485:2016, EU MDR 2017/745, Directive 93/42/CEE, GMP 21CFR part 820 : inspection participation (frontroom & backroom).

  • Sanofi
    • France
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Quality Coordinator
      • Nov 2017 - May 2018

      - Onboarding program management- Quality training animation (onboarding training, QeDoc / Esigns, HEP elearning / manager, mentoring training)- Human Error Prevention and Achieving Results in a GMP Environment training program planification and management - Training Guideline final quality approbation for sector- +QDCI implementation support for the Training & Documentation departmentBPFICHQ10 / Q9GMP 21CFR Parts 210 and 211 - Onboarding program management- Quality training animation (onboarding training, QeDoc / Esigns, HEP elearning / manager, mentoring training)- Human Error Prevention and Achieving Results in a GMP Environment training program planification and management - Training Guideline final quality approbation for sector- +QDCI implementation support for the Training & Documentation departmentBPFICHQ10 / Q9GMP 21CFR Parts 210 and 211

  • FAMAR
    • Greece
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Supplier Quality Assurance Specialist
      • Sep 2016 - Oct 2017

      - Implementation of a remediation plan for the agreements of the packaging suppliers- Suppliers agreement : preparation of agreements files and analysis of the suppliers documentation- Suppliers claims management and release of claimed batch at reception- Risk analysis : updating of API and excipient risk analysis for the Falsified Medicines Directive- Support for the collection of suppliers ICHQ3D data- Participation in change management for raw material and packaging- External audit management : preparation, completion and report redactionBPFICHQ10 / Q9

  • Merial
    • Germany
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Supplier Quality Assurance Assistant
      • Sep 2014 - Jul 2016

      - Implementation of reduced testing and sampling delegation with the raw material and packaging suppliers,- Specifications and quality agreement creation and updating, - Supplier quality and technical data management and data basis updating, - Internal supplier documentation creation and updating,- Change control management.BPFICHQ9 / ICHQ10GMP 21CFR Parts 210 & 211 - Implementation of reduced testing and sampling delegation with the raw material and packaging suppliers,- Specifications and quality agreement creation and updating, - Supplier quality and technical data management and data basis updating, - Internal supplier documentation creation and updating,- Change control management.BPFICHQ9 / ICHQ10GMP 21CFR Parts 210 & 211

  • THEOLAUR Peintures
    • Chemicals
    • 1 - 100 Employee
    • QSE Assistant
      • Sep 2013 - Aug 2014

      - Implementation of a PDCA method in order to improve the operationnal under control with the QSE management system,- Internal audit, - Quality document creation and updating, - Production team awareness, indicators, dashboard,- CAPA plan follow-up, - Participation to ISO9001 : 2008 renewable certification.ISO9001 : 2008ISO14001OHSAS18001 - Implementation of a PDCA method in order to improve the operationnal under control with the QSE management system,- Internal audit, - Quality document creation and updating, - Production team awareness, indicators, dashboard,- CAPA plan follow-up, - Participation to ISO9001 : 2008 renewable certification.ISO9001 : 2008ISO14001OHSAS18001

  • Gießerei Heunisch Guss
    • Procurement Assistant
      • Apr 2013 - Jul 2013

      Administrative procurement support, supplier documentation (delivery note) control, participation to a comparative analysis concerning a raw material alternative source.Others : 3 months of a rewarding experience - german language improvement and cultural experience in 2 points of view : professionnal and personnal. Administrative procurement support, supplier documentation (delivery note) control, participation to a comparative analysis concerning a raw material alternative source.Others : 3 months of a rewarding experience - german language improvement and cultural experience in 2 points of view : professionnal and personnal.

Education

  • KEDGE Business School
    ISMQ - Management of Quality Superior Institute ("Titre de niveau I"​ equivalent to Master2), Quality, Safety & Environment Manager
    2016 - 2017
  • EI.CESI - Ecole d'ingénieurs du CESI
    Quality, Safety and Environment Manager ("Titre de niveau II"​ - equivalent to Master 1), Passed in May 2016
    2014 - 2016
  • IAE Toulouse, Ecole de Management de l'Université Toulouse 1 Capitole
    Bachelor's degree, SMEs Management and Sustainable Development - QHSE specialization
    2013 - 2014
  • Université de Limoges
    Two-year technical degree in marketing and commercial techniques, Passed
    2011 - 2013

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