IVD Regulatory, Quality and Device Development Manager

• Oct 2020 - Present

Pharmaceutical Data Integrity Compliance Consultant

• Apr 2018 - Oct 2020

• Provide solutions to the IT Manufacturing department in order to ensure compliance with FDA 21 CFR Part 11 Data Integrity requirements • Manage related Deviations, CAPA and Change Controls • Reorganize department documentation in order to simplify and facilitate audits • Provide solutions to the IT Manufacturing department in order to ensure compliance with FDA 21 CFR Part 11 Data Integrity requirements • Manage related Deviations, CAPA and Change Controls • Reorganize department documentation in order to simplify and facilitate audits

Production and Laboratory Manager

• Sep 2014 - Nov 2014

Management of production, sub-contractor, customer delivery and laboratory building Management of production, sub-contractor, customer delivery and laboratory building

Medical Device Quality and Production Manager

• Feb 2012 - Aug 2014

• Industrialize the product under Medical devices directive 93/42/EEC and Personnel Protective Equipment directive (89/686/EEC) directives: establish regulatory and quality framework, break down directives into quality and production requirements • Establish and maintain contact with subcontractors and suppliers: assess and validate suppliers, lead trials and quality audits, establish quality agreements • Implement ISO13485: integrate the quality management system, implement Standard Operating Procedures internally and externally, train staff, prepare certification audit • Lead ISO14971 Risk assessment • Plan and control production and traceability, establish documentation, issue purchase orders and plan production according to demand planning • Ensure flawless delivery of the product on a daily basis: record and follow-up on non-conformities, ensure implementation, follow-up and closure of CAPA, root cause analysis • Manage technical aspects of the company: installation of a server, purchasing and maintenance of computers and softwares, ensure interim management of logistics and shipping, create and implement purchasing procedures, manage production purchasing, manage recruitment of the Customer Service Coordinator, review CV’s and lead interviews Show less

Startup and commissioning Spare parts Manager

• Apr 2011 - Jan 2012

• Establish spare parts recommendation lists for Gas Plants • Manage sourcing of spare parts from over 40 different vendors worldwide • Ensure spares delivery to agreed location and customer communication • Establish spare parts recommendation lists for Gas Plants • Manage sourcing of spare parts from over 40 different vendors worldwide • Ensure spares delivery to agreed location and customer communication

Associate Clinical Project Manager

• Feb 2009 - May 2010

• Management and Set-up of 18 outsourced clinical studies • Project Management: specifications writing, planning, budget management, laboratories coordination, logistics coordination • Interfacing between sponsors, internal departments, referral laboratories, subcontractors • Management and Set-up of 18 outsourced clinical studies • Project Management: specifications writing, planning, budget management, laboratories coordination, logistics coordination • Interfacing between sponsors, internal departments, referral laboratories, subcontractors

Chemicals Production Engineer

• Jan 2008 - Jan 2009

• Transfer processes for 8 new products from development to workshop • Daily workshop management: promote and report on quality and safety, coordinate with planning department • Set up, update and manage the distillation workshop documentation, procedures and yields • Transfer processes for 8 new products from development to workshop • Daily workshop management: promote and report on quality and safety, coordinate with planning department • Set up, update and manage the distillation workshop documentation, procedures and yields