Experience

SEQENS

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Assurance Manager

  • Feb 2021 - Present

  Villeneuve-la-Garenne, Île-de-France, France Deputy to the Site Quality Manager Release of Active Pharmaceutical Ingredients (API) in GMP environment Management of quality events related to the product (OOS / OOT / deviations / recalls / returns / complaints) Process validation and analytical methods validation Change control management Response to regulatory affairs requests related to regulatory files (EU, US, Brazil, Japan,...) Supplier management - qualification, follow-up, complaints Quality risk management… Show more Deputy to the Site Quality Manager Release of Active Pharmaceutical Ingredients (API) in GMP environment Management of quality events related to the product (OOS / OOT / deviations / recalls / returns / complaints) Process validation and analytical methods validation Change control management Response to regulatory affairs requests related to regulatory files (EU, US, Brazil, Japan,...) Supplier management - qualification, follow-up, complaints Quality risk management according to ICH Q9. Update of documentation (SOP, work instructions) related to the site activity in compliance with GMP Regulatory audits - site inspected regularly by ANSM (France), FDA (USA), ANVISA (Brazil), PMDA (Japan) and TMMDA (Turkey) - lead auditee during the ANSM inspection conducted in 2022. ERP key-user for the quality processes (ERP used : JD Edwards)

• Product Quality Assurance Engineer

  • Apr 2019 - Feb 2021

  Villeneuve-la-Garenne, Île-de-France, France Release of API batches Evaluation of events related to production (OOS / OOT / deviations) Change control evaluation Batch record review Supplier management - qualification, follow-up, complaints Regulatory audits - site inspected regularly by ANSM (France), FDA (USA), ANVISA (Brazil), PMDA (Japan) and TMMDA (Turkey)



Curium Pharma

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Validation Engineer (Consultant)

  • Feb 2019 - May 2019

  Saclay, Île-de-France, France Qualification of sterile HVAC systems (injectables) - Cleanroom validation Qualification protocols (IQ, OQ, PQ) Execution and follow-up of the tests Qualification reports Periodic requalification



EFOR

• France
• Business Consulting and Services
• 700 & Above Employee

• Consultant (Quality Assurance, Process industrialization)

  • Sep 2017 - May 2019

  Paris Area, France Consulting Engineer in : + Quality Assurance and cGMP compliance + Pharmaceutical Process Development and Industrialisation EFOR est un groupe national de conseil résolument tourné vers l’individu qui rassemble des consultants passionnés par leurs métiers. Notre groupe se caractérise par sa volonté de rassembler avant tout des personnalités. Nous sommes en effet convaincus qu’au delà des compétences et des expériences de chacun, notre plus grande force réside dans chacune… Show more Consulting Engineer in : + Quality Assurance and cGMP compliance + Pharmaceutical Process Development and Industrialisation EFOR est un groupe national de conseil résolument tourné vers l’individu qui rassemble des consultants passionnés par leurs métiers. Notre groupe se caractérise par sa volonté de rassembler avant tout des personnalités. Nous sommes en effet convaincus qu’au delà des compétences et des expériences de chacun, notre plus grande force réside dans chacune des personnalités des membres de nos équipes. … AU DELÀ DES INGÉNIEURS, IL Y A DES PERSONNALITÉS Show less



PCAS

• France
• Chemical Manufacturing
• 1 - 100 Employee

• Pilot and Process Engineer (Consultant)

  • Oct 2018 - Feb 2019

  Limay, Île-de-France, France Process industrialization at Pilot scale (20-50 kg) Master Batch record creation Follow-up of the synthesis in the workshop, follow-up of deviations and changes Project Management - initiating and following raw materials purchase and qualification, planning of production, interface with Quality Control and R&D laboratory on delays, establisment of campaign reports after synthesis, client information.

• ERP Implementation Engineer (Consultant)

  • Apr 2018 - Oct 2018

  Longjumeau, Île-de-France, France + Help Implementation Process of a new version of JDE (ERP) + Coordinate and guide sites in the implementation process + QA training guides writing - English and French + Update processes and associated documentation of Limay site + Conduct training sessions of QA personnel

• Quality Assurance Engineer (Consultant)

  • Dec 2017 - Apr 2018

  Porcheville, Île-de-France, France HVAC - Air Treatment Systems - Clean Room Qualifications + Protocol (IQ, OQ, PQ) and report + Tests execution & tests review + Management of non-conformities + Teamwork Management of measurement equipment + Inventory and monitoring laboratory and pilot-scale equipments + Tracking and ensuring on-time equipement calibration Deviation management + Investigation + Documentation Quality Assurance Management System + Implementing SOPs in compliance… Show more HVAC - Air Treatment Systems - Clean Room Qualifications + Protocol (IQ, OQ, PQ) and report + Tests execution & tests review + Management of non-conformities + Teamwork Management of measurement equipment + Inventory and monitoring laboratory and pilot-scale equipments + Tracking and ensuring on-time equipement calibration Deviation management + Investigation + Documentation Quality Assurance Management System + Implementing SOPs in compliance with the cGMP and ISO 9001



CHANEL

• United Kingdom
• Retail Luxury Goods and Jewelry
• 700 & Above Employee

• Process Development Engineer

  • Feb 2017 - Aug 2017

  Paris Area, France In charge of: + Conceivng a new process of extraction of natural substances from plants + Developing the process in multiple steps - extraction, purification and chemical modification of the molecule-of-interest in order to obtain the final active ingredient + Optimising each step of the process using Design of Experiments (DoE) + Scaling-up the process The process is imagined to be environmentaly-friendly giving a 100% natural product.



Bulgarian Students in France Assocation

• Treasurer

  • Dec 2012 - 2017

  Paris Area, France http://assobg.org/fr/



PCAS

• France
• Chemical Manufacturing
• 1 - 100 Employee

• Quality Assurance Engineer

  • Mar 2016 - Aug 2016

  Villeneuve-la-Garenne, Île-de-France + Implementation of Current Good Manufacturing Practices (cGMP) Project management, Time management, Teamwork + Risk analysis according to ICH Q9 methodology Identifying critical risks of cross-contamination in active principle/drug manufacturing and proposing solutions to reduce these risks to an acceptable level + Equipment requalification - deviations, equipment modifications, preventive and curative maintenance, P&ID diagrams (yellow review)



Ludwig-Maximilians-Universität München

• Germany
• Higher Education
• 700 & Above Employee

• Research Assistant

  • May 2015 - Sep 2015

  Munich Area, Germany AK Prof Dr Hendrik Zipse Selective protection of polyols Development of new nucleophilic catalysts for selective silylation/acylation of alcohols Kinetic studies for characterization of catalyst efficiency (NMR and GC) Theoretical studies of conformational properties of the reaction components