ALEXIA BIGNON
QASCV Specialist
35 years old
Driving License
Professional Status
Employed
Available
About Me
Experienced professional in computer system validation for over 7 years. I am currently working as a QACSV specialist for Univercells.
I have a strong background in the pharmaceutical industry and have developed experience in the medical device field.
I strongly believe that good communication and a positive attitude are mandatory in the workplace.
I have many interests such as yoga, meditation, board games, video games, drawing and so on!
I have a strong background in the pharmaceutical industry and have developed experience in the medical device field.
I strongly believe that good communication and a positive attitude are mandatory in the workplace.
I have many interests such as yoga, meditation, board games, video games, drawing and so on!
IS VALIDATION CONSULTANT
SANOFI (R&D)
November 2015
to February 2018
- AGILE methodology
- Provided expertise and advice to project teams on computerised systems validation activities to meet GxP's regulatory needs using a risk-based approach.
Coordinated risk assessment and ensured that validation activities are performed based on the assessed risks. Worked on WISE (Worldwide Integrated SaaS Environment) and its satellite applications. Participated in the migration of Empower within the Caducée project and migration from CTP to "CeDOC-PHARMA" (eTMF). - Validation Expert
- Responsible for methodology and regulatory compliance of GxP IT systems, Carried out the periodic review of regulated software,
Exchanged with suppliers, Participated in project meetings, Decision-making on methodology, Participated in risk assessment.
Proofreading quality validation. - Quality Representative
- Participated in change control evaluation, Reviewed key documents (validation plan/report, authorization for use, criticality assessment, risk assessment), Opened of CAPAs and ensured their follow-up, Evaluated non-conformities, Trained project actors to the methodology.
