Kamlesh K.
Senior CSV Consultant at Wipro| Life sciences & Healthcare
- Role
- Csv Engineer at Wipro
- Location
- Pune Division, MH, IN
- LinkedIn followers
- 500 followers
About Kamlesh K.
having 8+ years experience in IT Quality Assurance and software testing in an SDLC…
Experience
Csv Engineer
Jan 2022 — Present · Pune, IN
System Validation & ComplianceDevelop and execute validation plans, protocols (IQ, OQ, PQ), and reports.Ensure compliance with industry regulations such as FDA 21 CFR Part 11, GxP, HIPAA, GDPR, and ISO 13485.Perform risk assessments to identify potential compliance gaps.Maintain validation documentation for audits and inspections.2. Validation Documentation & TestingCreate Validation Master Plans (VMP), User Requirements Specifications (URS), and Functional Specifications (FS).Write and execute test scripts for software applications and IT systems.Conduct data integrity assessments to ensure accuracy, consistency, and reliability.Perform Change Control Management to evaluate system updates or modifications.3. System Implementation & QualificationLead validation efforts for new system installations, upgrades, or migrations.Conduct Installation Qualification (IQ) – Verify system installation according to specifications.Perform Operational Qualification (OQ) – Test system functionality under expected conditions.Execute Performance Qualification (PQ) – Ensure system performs as intended in real-world scenarios.4. Automation & Process ImprovementImplement automated validation tools to improve efficiency.Develop scripts for automated CSV testing and reporting.Optimize validation processes to align with Agile, GAMP 5, or SDLC methodologies.5. Audit Support & Regulatory ComplianceSupport internal and external audits by regulatory agencies (FDA, EMA, MHRA).Address compliance gaps and propose corrective actions (CAPA – Corrective and Preventive Actions).Provide training on validation best practices for IT and quality assurance teams.6. Cross-Functional CollaborationWork with IT, Quality Assurance (QA), Regulatory Affairs, and Manufacturing teams.Communicate validation findings and recommend system improvements.Support vendor qualification and third-party software assessments.
Education
Savitribai Phule Pune University
Master's degree, Computer Science
2013 — 2015
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