Activities :

• Perform requirement analysis for new regulatory systems and all the changes in the regulatory systems. Understand business standards and project needs. Work with technical and business team for clarify on the requirements/specifications
• Support validation lead with validation documentation
• Author Validation protocols (OQ/PQ/Change Control Document) as per the requirements and test scenarios, and update Traceability Matrix
• Apply risk-based approach to validation
• Execute validation activities for software product’s general releases, hot fixes, as well as system’s periodic revalidation
• Perform dry run and formal execution of validation protocols. Capture test results and artifacts, as necessary. Track and report defects
• Assist with investigation and root cause analysis for deviations
• Work with the change control team for testing and validation related activities from change creation till change closure
• Provide support for the periodic review and annual maintenance activities for regulatory systems

Requirement:

• Knowledge, prior experience and demonstrated success with testing/validation for medium to large system implementations
• Experience working with Waterfall, Iterative and Agile methodologies
• Proficiency with Microsoft Office Suite (Project, Visio, Excel and PowerPoint)
• Proficiency with HP ALM
• Broad technical knowledge including experience with SaaS and Cloud systems in a GxP environment
• Excellent verbal and written communication skills
• Ability to work on multiple concurrent projects
• Thorough knowledge of GxP compliance including 21 CFR Part 11, and CSA guidelines
• Bachelor’s or Master’s degree with 2+ years of experience in computer systems validation and testing
• Experience and education in Life Sciences or pharma preferred
• Flexibility to work in different time zone hours and travel as required

Key Skills: CSV Validation, GxP Applications, SOP’s, IQ,OQ, PQ, Manual Testing