Swarup Silla
Computer System Validation And Compliance
Rikapalli, Chatrapur,OD
Summary
Senior Consultant leading computerised system validation and cloud-based infrastructure validation across regulated environments. Reviews and signs off SLC deliverables, authors validation documents from ITRA through validation summary reports, and supports change management, incident, defect, and data correction activities in Jira, Azure DevOps, ALM, and Quality Docs. Improves validation delivery through procedure training, automation support, and closed-premise AI-assisted process ideas.
Overview
12
12
years of professional experience
Work History
Senior Consultant
Ernst and Young India
07.2025 - Current
- Responsible for handling end to end validation of Category 5 and cloud based Infastucture.
- Responsible for reviewing and signing off SLC deliverables in document repositories i.e. Azure Devops, Quality Docs and HP ALM etc.
- Experience in Authoring and reviewing of validation documents across the validation life cycle like ITRA, Validation plan, FS, DS, CS, Test Plan (IQ, OQ, UAT,)Design and configuration Documents, RTM, Validation summary report, Promotion form, CIL documents etc.
- Imporvization on the project process on validation standpoint i.e the bringing strategic approach with the available resource and process, using AI agents in a closed premise , automation and critical thinking etc.
- Responsible for training and improvisation of procedures.
- Planning and reviewing the change management, incident, Defect and Quality deliverables.
- Providing guidance to users on their queries and issues.
- Handling of Operational activities Incidents, Change management, Deviation, Data correction etc.
- Tools used Jira,Azure Devops, ALM and Quality docs for Requirements , Specification and Test Management.
- Support for implementation of Automation test cases and its execution.
Application Development Specialist
Accenture Solutions Pvt ltd
11.2021 - 07.2025
- Responsible for reviewing the Scope of change and doing initial Planning Prior to Project by coordinating with client and CFT with various CAT- 4 & 5 software’s i.e. SAP S4 HANA, EAMS,GlobalLIMS interfaces (GLSCA,CIA) iOS Apps, Scigenics SCADA for fermenter etc.
- Responsible for reviewing and signing off SLC deliverables in document repositories i.e. SOLMAN, CHARM, Quality Docs etc.
- Experience in Authoring and reviewing of validation documents across the validation life cycle like ITRA, Validation plan, FS, DS, CS, Test Plan (IQ, OQ, UAT,)Design and configuration Documents, RTM, Validation summary report, Promotion form, CIL documents etc.
- Reviewing test scripts DTS, ST, UAT or IV, OV, PV, pIV using ALM, JIRA, Azure Devops.
- Leading and managing validation activities in synchronisation with project scope, schedule and objective related to release specific
- Responsible for training and improvisation of procedures.
- Planning and reviewing the change management, incident, Defect and Quality deliverables.
- Providing guidance to users on their queries and issues.
- Handling of Operational activities Incidents, Change management, Deviation, Data correction etc.
- Tools used Jira,Azure Devops, ALM and Quality docs for Requirements , Specification and Test Management.
- Support for implementation of Automation test cases and its execution.
Team Member
Dr.Reddys Laboratories
12.2019 - 11.2021
- Prepared test plans and protocols for software validation, then executed testing against approved requirements and procedures.
- Tested installed software against validation protocols and documented compliance throughout the qualification lifecycle.
- Supported risk assessment, gap analysis, deviation handling, incident investigation, CAPA, CC, RTM, and summary reports.
Sr.EXECUTIVE
Syngene international
02.2019 - 12.2019
- Planned biological and QC lab projects, supporting computerised system validation for equipment and software compliance.
- Led risk assessments for installation, commissioning, qualifications, fermenters, and steam generators in biologics environments.
- Resolved equipment and software issues, categorized critical alarms, and managed periodic backups, user access, and privilege reviews.
Jr.EXECUTIVE
Pfizer Healthcare India pvt ltd
03.2016 - 01.2019
- Planned and executed computerised system validation for manufacturing automation, applying a GAMP risk-based approach and 21 CFR Part 11, EU Annex 11 controls.
- Coordinated instrument calibrations, preventive maintenance, SOP preparation, and vendor qualification for measuring and master instruments.
- Supported SCADA reconfiguration, IQ/OQ/PQ activities, and software testing for manufacturing systems with controlled user access and traceability.
TRAINEE /Jr.Executive
BHARAT BIOTECH INTERNATIONAL LIMITED
08.2014 - 04.2016
- Authored and reviewed SOPs for calibration, strengthening controlled documentation and day-to-day compliance support.
- Prepared project planners and measuring instrument lists for in-house calibration, while coordinating assigned project teams.
- Led calibration work for BIO POLIO and ROTA BLOCK projects, managing system risk assessments, gap analysis, and action-plan reviews.
- Implemented corrective and preventive actions for calibration and maintenance activities, then resolved daily troubleshooting issues with practical remediation.
- Supported WHO audit preparation and response, reinforcing compliance readiness across systems and project documentation.
Education
B.Tech - Electronics and Instrumentation Engineering
Apex Institute of Technology and Management, BPUT
Bhubaneshwar06-2013
Skills
Computerised system validation
Instrumentation and Automation
GAMP risk-based approach validation
EU Annex 11 compliance
GDP
GAMP
Jira
21 CFR Part 11 compliance
Timeline
Senior Consultant
Ernst and Young India
07.2025 - Current
Application Development Specialist
Accenture Solutions Pvt ltd
11.2021 - 07.2025
Team Member
Dr.Reddys Laboratories
12.2019 - 11.2021
Sr.EXECUTIVE
Syngene international
02.2019 - 12.2019
Jr.EXECUTIVE
Pfizer Healthcare India pvt ltd
03.2016 - 01.2019
TRAINEE /Jr.Executive
BHARAT BIOTECH INTERNATIONAL LIMITED
08.2014 - 04.2016
B.Tech - Electronics and Instrumentation Engineering
Apex Institute of Technology and Management, BPUT