Sr. Consultant Jobs Opening in Amneal Pharmaceuticals Private Limited at Ahmedabad
FEATURED JOBCSV
organization.
Job Description
Lead and manage Computer System Validation (CSV) activities for GxP
systems in line with FDA 21 CFR Part 11, Annex 11, and other applicable
regulations.
Ensure validation of systems across global project landscapes, including
ERP (SAP), LIMS, MES, TrackWise, and other laboratory/enterprise systems.
Prepare and review validation deliverables such as Validation Plans, Risk
Assessments, IQ/OQ/PQ protocols, Traceability Matrix, and Validation
Summary Reports.
Collaborate with IT, Quality Assurance, and system owners to ensure
compliance with internal policies and international regulatory standards.
Support audit readiness and participate in regulatory inspections or internal
audits.
Establish and maintain CSV SOPs and templates, and provide training to
internal teams.
Act as a subject matter expert (SME) for CSV in global pharma projects.
Manage validation project timelines, resources, and deliverables effectively.
