CSV Profiles

1. Design, Author, and Execute Computerized System Validation (CSV) according to GAMP 5 guidance especially on Analytical Laboratory Test Equipment and other Lab Information Systems.
2. Technical Writing of Validation Documents (Risk Assessment, Validation Plan, Design Configuration/Specification, User Requirements, Functional Requirements, IQ OQ PQ, Trace Matrix, Validation Summary Report), SOPs, Maintenance Procedures, Calibration Procedures, and other instrument support documents
3. Perform and support compliance / validation activities.
4. Understand and adhere to the Client Regulations/Processes of Computerized System Validation concept with regards to document management, and V Model Methodology
5. Assessing the Functional Risk & Mitigation & preparation of Impact assessment validation documents with respect to application & Equipments.
6. Good knowledge of GMPs, 21CFR Part 11, USP 1058 and other relevant industry regulations and guidance
7. Customer-oriented, conducting job function with a primary focus on customer satisfaction (internal & external) and ability to deal with customer complaints
8. Translate technical information and requirements into qualification/validation test design.
9. Strong interpersonal skills and demonstrated ability work independently.