Sr Csv Analyst Job In Siera It Services Private Limited In Bengaluru / Bangalore

CSV Compliance Assessments and determining the risk level As applicable, prepare a milestones of Val deliverables for a Project During CSV Concept and Planning Phase, as applicable, draft/review and approve various plans as CSV Lead - Validation Plan Data Integrity/Migration Security Plan Business Continuity Plan and Disaster Recovery Plans Training Plan During Requirements, Design and Build Phase - Coordinate, Review and approve User/Functional/System/Data Migration Requirements Functional Risk Assessment at Requirement Level Protocols (pre and post review and approvals) - For Installation/Operation/Performance/Data Migration Qualification Config/Design specification documents Requirement Traceability Matrix Standard Operating Procedures on system intended use and system administration including Data Migration During Validation Phase - draft, collaborate, review and approve Qualification protocol execution and reporting - IQ, OQ, PQ, DMQ in GxP sensitive environments (as applicable) Review objective evidence at protocol level and sign-off Testing Summary Reports During CSV Release and Maintenance Phase - draft, collaborate, review and approve Qualification protocols execution in Prod - IQ, PQ, DMQ Review objective evidence at protocol level and sign-off Validation Summary Report Qualification/Validation of tools/utilities interacting with GxP sensitive environments Executing CAPA procedures, drafting and approving deviation logs and keeping artifacts audit-ready in MasterControl, ALM and ServiceNow tools Review and draft standard operating procedures the system and integrated tools refresh, upgrades, patching etc Project CHG management - CSV support to maintain the validated state Key Skills: Expert with ALM and ServiceNow Tools, knowledge of MasterControl would be a bonus

Csv Compliance Assessments And Determining The Risk Level As Applicable, Prepare A Milestones Of Val Deliverables For A Project During Csv Concept And Planning Phase, As Applicable, Draft/review And Approve Various Plans As Csv Lead - Vali

Siera It Services Private Limited is looking for Any Graduate / Post Graduate profile candidates.