- Over 3 years of experience in Life Science Industry with Software Development Life Cycle, 21 CFR Part-11 Validation, Change Control Management and implementation of business applications.
- Experience on working on Agile Projects and trained on Agile Methodology.
- Reviewed and Validated Computer Systems in compliance with 21 CFR Part 11 and GxP FDA Regulations.
- Experience in generating and reviewing Computer Systems Validations CSV Deliverables according to 21 CFR Part 11 and FDA regulations for the Pharmaceutical industries.
- Working knowledge of GLP, GCP, GMP, GDP, GAMP V guidelines especially in the areas of computer or related systems.
- Experience in preparation and review of Validation Protocols IQ/OQ/PQ documentation, VP, VSR, SOPs, Protocol Deviation, Risk Assessment, GAP analysis, CAPA and Periodic Review Report.
- Experience in reviewing User Requirement Specifications URS , Functional Requirements Specification FRS and Requirement Traceability Matrix RTM Documents.
- Excellent Knowledge and experience in Good Documentation Practices.
- Demonstrated capability to quickly gain a detailed understanding of a process in order to optimize efficiencies and improve quality.
- Reviewed and followed SOPs to help the business process in line with FDA regulations.
- Excellent experience in applying FDA regulations to the aspects of the Computer and Lab Systems.
- Trained project teams on SOPs and guidelines in order to ensure adherence to quality standards.