Abhay Jassal

SAP Lead @Cognizant

IN

Lead and coordinate the development and execution of validation deliverables for new GxP computerized systems, ensuring compliance with regulatory and business requirements. Perform cGMP compliance services focused on Computerized Systems Validation and Data Integrity, aligned with FDA, EMA, and other global regulatory expectations. Prepare comprehensive validation documentation, including Validation/Qualification Plans, Risk Assessments, User Requirements Specifications (URS), Traceability Matrices, and Test Plans (IQ/OQ/PQ). Support critical system activities such as data migration, SOP development, and change control processes. Ensure all computerized systems are fully compliant with internal policies, procedures, and external regulatory requirements throughout their lifecycle. Provide strategic CSV leadership and hands-on execution for new implementation projects, serving as the subject matter expert in validation compliance. Maintain validation lifecycle oversight, including re-evaluation, periodic review, and change management, ensuring ongoing system fitness and compliance. Regularly report project status to senior management, identifying and escalating risks or issues as needed. Co-approve change control records pre- and post-execution to ensure appropriate validation impact assessment and regulatory alignment. Offer expert guidance on issue resolution, supporting deviation management, CAPAs, and responses to audit observations.