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!
Risk assessment evaluation, Exchange with suppliers ,writting Gap Analysis, Review of the URS, writting validation protocols, redaction of validation plans, writting Traceability Matrix, writting test sheets and approval of test sheets and reports.
IT Business Quality Representative Change Advisory Board member, IT Demand Committee member, GxP Evaluation of Systems and Meetings organization on on-going topics to ensure actions follow-ups.
Operational QA CAPA, Deviation and change control follow-ups KPIs definition Meetings organization on on-going topics to ensure actions follow-ups.
Audit
Working with the supplier audit department to audit IT-related suppliers.
