Freelancer profile translated to English.
Back to original languageAbout Yao
Skills:
Food & Food Supplements
ISO (9001 _22000)_IFS Food:
o Registration of foreign manufacturing site: Health Canada, US FDA
o Definition, Implementation and Management of the Quality & Food Safety Management System
o ISO 9001, & 22000 Certification
o Development of process indicators
o Assistance in defining & Deploying control plans (IPC, PrPo & Stability)
o Personnel Training
o Supplier and Contractor Audits
Plastic, Cosmetic, Medical Device and Pharmaceutical Industry
[ISO22716_9001_13485_14001_15378_10993-1_ 2859]
o Consulting and assistance in Product Regulation with various internal departments (Sales, R&D, Site Quality, Marketing and Innovation)
- Situation assessment of the company's Drug Master File (active/inactive) status
- Drafting of Letter of Authorization (LoA) for pharmaceutical clients and communication to the FDA
- Review of technical documentation for medical devices (FMEA, product plan…)
- Review of client CDCs, synthesis of requirements and product specifications (regulatory compliance, Sampling method, reception control and analysis, …)
- Analysis of the impact of ICH Q3D in plastics (packaging and containers)
- Monitoring and updating of quality indicators
- Certification audits, client audits, process audits and internal audits (6S)
- Conducting training on GMP and the use of EDMS (VDoc)
- EDMS implementation, workflow creation monitoring_ Use of MRP (SILVER CS)
- Management of Customer/Supplier/Subcontractor Complaints/Incidents
Pharmaceutical Industry [OECD GLP_21 CFR Part 58_ICH Q10_ICH Q2(R1)_BARQA GCLP_Pharmacovigilance]
o Management of computerized audit systems (TRACKWISE R&D,PHENIX)
o Performance indicator monitoring
o Implementation of documentary databases
o GLP Audits & ANSM Inspection
French
Native or bilingual
English
Fluent
Can work on-site
Nîmes (up to 50km), Avignon (up to 100km), Paris (up to 100km), Bordeaux (up to 100km)
Experience
- FURSTPLASTQHSE and Site Management Subject Matter ExpertAGRICULTUREMarch 2022 - Today (4 years and 3 months)Responsible for the overall leadership, strategic direction, and operational excellence of the manufacturing site. This includes overseeing production, quality, engineering, supply chain, EHS (Environment, Health & Safety), and regulatory compliance. Ensuring the Site meets business objectives, regulatory standards, and customer expectations while fostering a culture of continuous improvement and innovation
- IRATI INTERNATIONALQuality Management ManagerAGRICULTUREJuly 2016 - April 2020 (3 years and 9 months)Les Angles, FranceImplementation and Management of the company's QHSE management system.Selection and approval of production suppliers and subcontractors.
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Education
- Master's degree in Biotechnology R&DUPMC & IPROB2013Création d’entreprise et PME Management, grandes fonctions de l’entreprise et gestion des potentiels Gestion des ressources humaines Métiers du secteur des biotechnologies R&D, Qualité, Développement, Affaires règlementaires, Industrialisation et Production Veille stratégique et intelligence économique Connaissance et dynamisation personnelle Communication interpersonnelle Génie immunologique Génie génétique Culture cellulaire Bioinformatique Bioéthique