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!
Validation Expert Participated in the QC equipment remediation project, data integrity issues and data integrity verification program. Assisted QC teams on ongoing and new validation projects. Participated in the migration of Empower within the Caducée project (PUMA methodology application) and in the migrations of small QC applications (softmaxpro, WinKQCL,...).
Quality Representative Participated in the evaluation of change controls. Reviewed key documents (validation plan/report, authorization for use, criticality assessment, risk assessment). Evaluated non-conformities. Responsible for methodology and IT systems regulatory compliance .
GxP Expert Conducted periodic review of regulated software, Exchanged with suppliers, Participated in project meetings, Decision making on methodology, Led risk assessment meetings and proofreading on validation documents.
Management Followed-up and defined consultant's actions for validation activities
