Avinesh Kumar Email & Phone Number

Validation Expert/Quality Representative (Analyst) with 5 years of expertise in defining and managing validation controls and protocols in the field of Computerized System Validation in Life Sciences and Healthcare domain. Roles/Responsibilities and core competencies:• Precise Understanding of 21 CFR part 11, EU Annex 11, GAMP 5, USFDA guidelines, CAPAs and Events, Drug development process, ICH-GCP, Clinical Data Integrity.• Responsible for end-to-end validation, qualification and project execution for IT systems in GxP (GCP, GMP, GLP, GPV) Area.• Subject Matter Expert in ITSM, Change Management and Incident/Problem Management process to comply with applicable internal directives, user and regulatory requirements of GxP IT system in its lifecycle.• Responsible for defining/documenting validation and test strategy GxP IT systems (core software applications and customized/configured solutions).• Conducted System criticality Assessment and Periodic review of GxP IT System.• Played key role in Data Migration and Disaster Recovery activities of in-house developed and SaaS based GxP IT systems.• Conducted Retirement (Archiving and Decommissioning) activities of centralized and distributed GxP IT systems.• Held different roles like Author, Reviewer and Approver of CSV deliverables required as evidences for compliance (for e.g., Project Plan, Validation Plan, Authorization for Use, Validation Report, Release Plan, Release Summary, System specifications including User Requirement Specifications, Functional and Design specifications, Architecture specifications, Functional Risk Assessment, Installation Qualification Design and Reports, Test Plans, Test Design, Test Scripts, Test executions, Test Summary Reports, Requirements-Traceability Matrix).• Proficient in ITSM tools like ServiceNow, HP-ALM, eDMS systems like Geodis and Geode+, GIRA and Confluence.• Worked closely with all involved departments, project team members and IT vendors throughout the entire IT system/ software development life cycle.• Worked closely with Quality Operation team for updating the Global Operating procedures and SOPs.