Job Responsibilities Review CSV deliverables Validation Plan User Requirements URS Functional Specifications FS Risk Assessments IQ OQ PQ protocols Traceability Matrices Validation Summary Reports Perform system risk assessments to identify GxP impact and required validation Review Installation Qualification IQ Operational Qualification OQ and Performance Qualification PQ testing Ensure compliance with FDA 21 CFR Part 11 EU Annex 11 MHRA ICH Q7 Q9 guidelines Support audits and inspections internal regulatory client Collaborate with IT QA Manufacturing and Business to ensure validation of ERP LIMS MES CDS QMS and other GxP systems Maintain validation documentation as per SOPs Participate in Change Control CAPA and Deviation management related to computerized systems Provide training and guidance on CSV processes and best practices Contribute to transitioning from CSV to CSA Computer Software Assurance approach where applicable Technical Skills Required CSV lifecycle and GAMP 5 guidelines Advanced 21 CFR Part 11 and Annex 11 compliance Advanced Proficiency in writing validation documents URS FS RA IQ OQ PQ VSR Advanced SDLC System Development Life Cycle and risk-based validation Advanced Exposure to Computer Software Assurance CSA approach Advanced B-Pharmacy M-Pharmacy Amneal is an equal prospect employer We do not discriminate based on caste religion gender disability or any other legally protected status We believe in fostering a workplace that values diversity and inclusion