Manager – Computer System Validation - Scitara Technologies Pvt. Ltd.
(2024-06 - 2026-01)
- Supported validation and verification activities for laboratory platforms and computerized systems integrated systems in regulated GxP environments.
- Performed CSV activities for Scitara DLX iPaaS platform ensuring compliance with regulatory standards.
- Prepared validation documentation including Validation Plans, IQ, OQ, PQ protocols, and summary reports.
- Executed manual testing activities including Regression Testing, Integration Testing, Sanity Testing, Functional Testing, and User Acceptance Testing (UAT) across various GxP and non-production environments.
- Managed defect tracking, issue resolution, test evidence documentation, and validation traceability activities.
- Collaborated with cross-functional teams, customers, and vendors for requirement gathering and validation activities.
- Reviewed deviations, change controls, CAPAs, and incident reports.
- Contributed to improvement of departmental SOPs and validation practices.
Manager – Projects - Cognizant Technology Solutions
(2023-08 - 2024-06)
- Managed project execution and application support activities for laboratory systems.
- Led project teams and coordinated tasks to ensure timely delivery.
- Acted as primary client contact for system support, upgrades, and issue resolution.
- Coordinated vendor activities and system configuration updates.
- Prepared and executed validation documentation to ensure regulatory compliance.
Manager – Projects - Cognizant Technology Solutions
(2021-10 - 2023-08)
- Subject Matter Expert for Electronic Laboratory Notebook (ELN) upgrades.
- Managed project teams responsible for system configuration, testing, and deployment.
- Coordinated with vendors and stakeholders to implement new system requirements.
- Monitored incident and service requests using Jira and ServiceNow.
- Executed system testing using HP ALM following infrastructure updates.
Senior Specialist – Quality Engineering - L&T Infotech
(2021-01 - 2021-09)
- Prepared and reviewed validation documentation including design specifications and change qualifications.
- Executed validation protocols (IQ/OQ) ensuring alignment with project requirements.
- Configured customer environments and supported serialization compliance activities.
- Prepared SOPs and conducted system testing before go-live deployment.
ELN – CSV & Quality Assurance - Cipla Pharmaceutical
(2017-03 - 2021-01)
Supported validation and verification activities for computerized systems, laboratory instruments, and medical device-related applications aligned with regulatory and quality requirements. Led implementation and validation of Electronic Laboratory Notebook (ELN) platform. Prepared validation and verification documentation including IQ, OQ, PQ, risk assessments, traceability matrices, and validation reports.
- Performed manual testing including Regression Testing, Integration Testing, Functional Testing, Smoke Testing, and Sanity Testing across various GxP and non-production environments.
- Coordinated defect tracking, issue management, and test execution activities.
- Gathered business and user requirements in coordination with stakeholders and vendors.
- Worked closely with cross-functional teams for system enhancements, testing, deployment, and compliance activities.
- Managed deviation investigations, root cause analysis, and CAPA implementation.
- Conducted user training and demonstrations for system enhancements.
Development Quality Assurance - Cipla Pharmaceutical
(2008-12 - 2017-03)
- Supported SAP MM/PP system implementation and validation activities including UAT, defect tracking, validation documentation, and compliance verification in GxP-regulated environments.
- Prepared and reviewed Site Master File (SMF) and quality documentation.
- Conducted internal audits, deviation investigations and CAPA monitoring.
- Implemented systems including Documentum, LMS, SAP and Chromeleon.
- Coordinated laboratory operations including instrument qualification and documentation.
Analyst / QA Roles
(2007 - 2008)
Earlier Career
- Performed analytical testing using HPLC, dissolution and UV-Visible spectroscopy.
- Conducted heavy metal analysis and laboratory QA activities.
- Supported documentation review and GMP compliance activities.
