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!
Remediation 21 CFR part 11 of the Quality Control (Empower 3, Gen5, Omnic, Picta 1.7) and Supply Chain (TempTale) softwares to meet GxP's regulatory needs using a risk-based approach.
Computer Validation
Organized and led project meetings, Risk assessment evaluation, Exchange with suppliers, Wrote Gap Analysis, Wrote the URS, Wrote validation protocols, Wrote the validation plans, Wrote Traceability Matrix, Wrote test sheets and Approved test sheets and reports.
