Bhavya A

Life Sciences professional with 5 years of experience spanning Computer System Validation (CSV), GxP compliance, and Quality Control/Clinical Laboratory compliance, including 2 years of specialized experience in CSV and 3 years in Quality Analyst/QC laboratory compliance. Experienced in the end-to-end computer system validation lifecycle, including URS, FS/FRS, DS, Risk Assessment, RTM, IQ, OQ, PQ, and Validation Summary Report (VSR), with strong knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, FDA requirements, GMP, GLP, and Data Integrity principles. Proven ability to prepare and review audit-ready validation documentation, execute software validation activities, assess computerized systems for regulatory compliance, and collaborate effectively with QA, IT, Engineering, Laboratory, and Business teams.

Senior Executive – Validation / Quality Compliance - STRIDES PHARMA LIMITED - Bangalore, Karnataka

(2021-04)

• Perform Computer System Validation (CSV) activities for software and computerized systems used in pharmaceutical and laboratory environments in compliance with applicable GxP, FDA, GMP, GLP, and EU regulatory requirements.
• Execute and support validation activities across the complete lifecycle, including URS, FS/FRS, DS, Risk Assessment, RTM, IQ, OQ, PQ, and Validation Summary Reports.
• Conduct 21 CFR Part 11 assessments to evaluate computerized systems for compliance with electronic records, electronic signatures, audit trail, access control, and data integrity requirements.
• Prepare, review, and maintain validation documentation including URS, SRS, Functional Specifications, Design Specifications, Risk Assessments, test protocols, test scripts, RTMs, and validation reports.
• Develop and execute software validation test plans and qualification protocols for computerized laboratory and pharmaceutical systems.
• Support data integrity assessments through evaluation of audit trails, user access controls, electronic records, backup and recovery mechanisms, and system controls.
• Ensure validation documentation is maintained in accordance with GAMP 5 and applicable regulatory expectations.
• Collaborate with QA, IT, Engineering, Laboratory, and Business stakeholders to ensure timely completion of validation deliverables and resolution of compliance-related issues.
• Participate in Quality Management System activities including Change Control, Deviation, Incident Management, QRM, CAPA, and Internal Audits.
• Support audit and inspection readiness by ensuring validation records, compliance documents, and supporting evidence are complete, accurate, traceable, and readily available.
• Participate in audit-readiness activities and simulations, contributing to improved document readiness, response readiness, and timely retrieval of compliance evidence.
• Support continuous improvement initiatives related to computerized systems, validation processes, and quality compliance.

Master of Science - Bangalore University (2019)

Bachelor of Science - Tumkur University (2017)