Gajaram Basavaraju
Bangalore
Summary
Seeking for a mid-level assignment in the CSV domain to hone my professional skills.
Results-driven and compliance-focused Computer System Validation (CSV) professional with 7+ years of experience in validating and maintaining GxP-regulated systems across pharmaceutical and life sciences domains. Computer System Validation (CSV) and Operational Quality professional with experience in validation and qualification of GxP computerized systems within regulated environments. Experienced in laboratory instrument qualification, computerized system validation, equipment lifecycle management, data integrity assessments, deviation and CAPA management, change control, periodic review, and audit readiness. Knowledge of GAMP 5, 21 CFR Part 11, EU GMP Annex 11, ALCOA++, GMP, and risk-based validation principles. Skilled in working with QA, QC, IT, Engineering, laboratory users, SMEs, and vendors to ensure laboratory systems and instruments remain compliant and in a validated state.
Overview
4
4
Languages
1
1
Certification
7
7
years of professional experience
Work History
Associate - Projects
Cognizant Technology Solutions
11.2024 - Current
- Perform end-to-end Computer System Validation (CSV) activities for GxP-regulated computerized systems, ensuring compliance with internal procedures and applicable regulatory requirements.
- Conduct GxP impact assessments, system risk assessments, and data integrity assessments to determine appropriate validation and control strategies.
- Managed CSV and operational quality activities across the complete system lifecycle while maintaining compliance with GxP, 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity requirements.
- Develop and execute IQ/OQ and PQ test scripts, document test evidence, and ensure deviations are appropriately investigated and resolved.
- Manage the validated state of computerized systems through change control, periodic reviews, incident management, upgrades, patches, and system enhancements.
- Support Operational Quality activities including deviation/incident assessment, investigation, CAPA, change control, quality risk management, and compliance monitoring.
- Perform periodic review activities covering system functionality, access controls, audit trails, security, incidents, deviations, changes, backup/restore, and overall compliance.
- Identify opportunities for continuous improvement, process optimization, and reduction of compliance risks within CSV and operational quality processes.
- Utilize tools like JIRA, ServiceNow, and HP ALM (PROTON) for managing validation workflows, test cases, issue tracking, and documentation lifecycle.
QC Executive
Granules India Limited
Hyderabad, India
02.2024 - 10.2024
- Prepare and review URS, functional specifications, risk assessments, validation plans, qualification protocols, test scripts, traceability matrices, and validation summary reports.
- Support qualification of laboratory instruments using IQ, OQ, PQ and/or instrument-specific qualification approaches, based on intended use and risk.
- Coordinate with QC laboratories, QA, IT, Engineering, vendors, and instrument manufacturers during installation, qualification, validation, troubleshooting, and remediation activities.
- Support internal audits, customer audits, and regulatory inspections by providing laboratory instrument qualification, CSV, operational quality, and data integrity evidence.
- Monitor and maintain training compliance, SOP adherence, and quality documentation for assigned systems and processes.
- Review audit trails and electronic records to identify potential data integrity issues and ensure compliance with ALCOA+ principles.
Bench Chemist
Central Drugs Testing Laboratory
Hyderabad
03.2022 - 06.2023
- Perform CSV and equipment qualification activities for GxP laboratory instruments and computerized laboratory systems throughout their lifecycle.
- Support qualification of laboratory instruments using IQ, OQ, PQ and/or instrument-specific qualification approaches, based on intended use and risk.
- Perform and support periodic reviews of laboratory computerised systems and instruments to verify continued compliance and fitness for intended use.
- Support vendor documentation review, including assessment of vendor specifications, qualification packages, test evidence, and software documentation.
Officer - 1 Quality Control
Medreich Ltd.
Bangalore
08.2019 - 12.2021
- Drive end-to-end Computer System Validation (CSV) activities for GxP-regulated applications, ensuring full compliance with 21 CFR Part 11, EU Annex 11, GAMP 5 guideline requirements.
- Develop and execute validation strategies aligned with risk-based GAMP 5 principles, covering the full system development lifecycle (SDLC) and emphasizing system reliability, data integrity, and regulatory compliance.
- Create and maintain comprehensive validation documentation including Validation Plans, User Requirements Specifications (URS), Functional Requirements Specifications (FRS), Traceability Matrices, and test protocols.
- Conduct Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for computerized systems, ensuring seamless execution and documentation of test cases.
- Perform impact assessments for system changes, determine re-validation requirements, and manage updates through a controlled change management process.
- Support and prepare documentation for internal audits, external inspections, and regulatory assessments; address audit findings and implement corrective and preventive actions (CAPAs).
- Collaborate cross-functionally with QA, IT, business analysts, and validation leads to ensure systems meet both technical specifications and compliance requirements..
Education
MASTER OF PHARMACY - Pharmaceutical Analysis
JNTUA
ANDHRA PRADESH01-2020
BACHELOR OF - PHARMACY
JNTUA
Anantapur, AP01-2018
INTERMEDIATE -
BOARD OF INTERMEDIATE EDUCATION
Tirupati01-2014
Skills
- Computer System Validation (CSV)
- GxP compliance
- 21 CFR Part 11 / EU GMP Annex 11, GAMP 5 Guidelines
- Data Integrity & ALCOA
- Risk Assessment / GxP Impact Assessment
- Computer Software Assurance (CSA)
- Decision Making
- Problem Solving
- Leadership
- Team Work
- Time management
Audit Participation
- Actively participated in USFDA, MHRA audits.
- Actively participated in various customer audits & system audits.
Accomplishments
- GPAT Qualified.
Software Expertise
- ServiceNow
- HPALM
- JIRA
- EQMS
- LIMS
- DocNav
- CoreDox
- Chromeleon
Custom
- Delegate in a National Conference on Advance Research in Pharmaceutical and Chemical Sciences - Emerging Challenges in Practice (NCARPC - ECP 2017), organized by JNTUA- oil technological & pharmaceutical research institute, Ananthapuramu, on 15 &16th of Sep-2017.
- Participated in a Science fair organised by Secondary Board of school Education on 2011-2012.
Certification
- NCC Certificate
Languages
English
Hindi
Telugu
Kannada
Timeline
Associate - Projects
Cognizant Technology Solutions
11.2024 - Current
QC Executive
Granules India Limited
02.2024 - 10.2024
Bench Chemist
Central Drugs Testing Laboratory
03.2022 - 06.2023
Officer - 1 Quality Control
Medreich Ltd.
08.2019 - 12.2021
MASTER OF PHARMACY - Pharmaceutical Analysis
JNTUA
BACHELOR OF - PHARMACY
JNTUA
INTERMEDIATE -
BOARD OF INTERMEDIATE EDUCATION