Job Description

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 opportunity 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.