Freelancer profile translated to English.
Back to original languageAbout Veronique
Are you directors, managers, quality project leaders, and are you asking yourself the following questions:
✔️How to integrate Data Integrity principles into my organization?
✔️ How to conduct the periodic review of audit trails?
✔️ How to prepare for an inspection by regulatory authorities (FDA, ANSM, ANVISA, etc.) and present a remediation plan?
✔️ How to validate Excel files and computerized systems?
✔️ How to audit IT service providers and suppliers (data centers, outsourcing, application solution providers, etc.)?
My profession •
◾I help and support pharmaceutical laboratories in implementing regulatory requirements related to Data Integrity and computerized system validation in their processes.
My services •
◾Tailor-made support for implementing regulatory requirements - Generally, the program is as follows: Audit – Establishment of a CAPAs Plan – Staff Training – Support.
◾Support for managers in amicably resolving their disputes.
◾Courses at the Faculty of Sophia Antipolis (Master FOQUAL) – Health Products EM
What matters to me? •
◾ Giving meaning, sharing my knowledge and passion, putting people at the center of my services, and motivating teams.
◾ In my opinion, simply applying regulations doesn't work because you need to understand the 'why' behind the 'how'.
Why me? •
◾ 30 years spent in a large pharmaceutical company, in the quality and risk management sectors.
◾ Good knowledge of pharmaceutical industry regulations, from R&D to the discontinuation of drug marketing.
◾ Over 20 computerized systems validated - 60 audits - 50 training sessions - several ongoing support projects.
◾ Genuine desire to share and give meaning.
French
Native or bilingual
Can work on-site
Le Cannet (up to 50km), Paris (up to 50km), Lyon (up to 50km)
Experience
- CAPE-Expert (Conseil Audit Prévention Expertise)President - FounderPHARMACEUTICALS INDUSTRYFebruary 2020 - Today (6 years and 6 months)Le Cannet, France✔Helps and supports pharmaceutical laboratories in implementing regulatory requirements related to Data Integrity and computerized system validation in their processes.
- CPA ExpertsExpert in AssuranceJanuary 2015 - December 2019 (4 years and 11 months)Management of high-stakes disputes in highly regulated sectors (similar to aerospace and nuclear) such as the manufacturing of medicines, medical devices, food supplements, cosmetic products, as well as in the agri-food sector.✔60 cases handled✔Some examples: Recalls of drug batches and site closure at the request of health authorities, Contamination of entrusted goods, Incorrect printing of drug leaflets (1 side instead of 2), Active ingredient weighing error, Sterile medicine vial and cosmetic product tube sealing problem, Presence of genotoxic impurity, Perfume active ingredient sending error, Use of a non-food active ingredient for lipstick manufacturing, Design problem with a medical bed, etc...✔Stakes: from tens of thousands of Euros to several million Euros.
- SANOFIInternational Quality Auditor - Computerized System ValidationJanuary 2013 - June 2015 (2 years and 5 months)Sand, FranceInternational Quality Auditor for computerized systems used by SANOFI, SANOFI Pasteur, GENZYME, and MERIAL✔50 audits conducted in Europe and the USA✔CAPA Management✔10 training sessions on auditing IT service providers and suppliers
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Education
- DESS - Master 2 's degree, Quality Assurance - Production, Quality Assurance - ProductionUniversité François Rabelais de Tours2002DESS - Master 2 's degree, Quality Assurance - Production, Quality Assurance - Production