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!
Act as a guide in System Validation of Software as a service (Saas) tools/cloud applications, Data Integrity, 21 CFR Part 11 Compliance (ER/ES), Audit Preparation and Support, Data Migration, and Release and Change Management Process.
Involved in the overall development and maintenance of GxP-related computerized and automated system lifecycle documentation, from business process description through system retirement.
This includes:
Validation (Master) Plans
User Requirements Specifications
Configuration, Functional, and Design Specifications
