Available to hire
I am Dara Malleswari Medisetty, a Quality, CSV and IT Validation & Compliance Specialist with 13+ years in IT, pharma, Biotech, and medical device industries. I am known for delivering inspection- and audit-ready documentation, ensuring GxP compliance, and driving continuous improvement in regulated environments.
I excel at risk-based IT system validation, cGMP, infrastructure qualification, QC/QA, and audit readiness for global authorities. I pride myself on delivering inspection-ready documentation and driving continuous improvement in regulated environments.
Experience Level
Intermediate
Intermediate
Intermediate
Intermediate
Language
English
Advanced
Danish
Beginner
Work Experience
IT Validation & Compliance Specialist at Novo Nordisk
October 1, 2022 - September 1, 2025Led IT Infrastructure Qualification and CSV activities, conducted IT risk assessments and GDPR reviews, data integrity checks, design reviews, test planning/execution, and defect management to ensure validated IT services. Ensured compliance of cloud and infrastructure services with QMS and regulatory guidelines, supported audits, delivered training, and acted as SME for risk migrations to ServiceNow, while managing configurations in ServiceNow and aligning with Agile practices for regulated environments.
Associate Manager, Quality Control at Pfizer Healthcare
May 1, 2019 - October 1, 2022Ensured audit readiness and responses for regulatory inspections and supplier audits; conducted CSV, CQV, and equipment/lab validations; maintained validated state of production IT systems; delivered GMP/GxP training; led DMAIC-driven investigations and managed CAPA/CCF/deviations/OOS/OOT and change control; prepared URRs, SOPs, protocols, and validation reports; supported continuous improvement within Agile and IMEx teams and supervised gLIMS operations.
Quality Reviewer & Compliance at Torrent Pharma Ltd
July 1, 2018 - April 1, 2019Ensured audit compliance; led internal audits and external vendor certifications; performed equipment/instrument qualification and periodic evaluations; coordinated regulatory inspections; maintained procedures; managed deviations, changes, OOS/OOT and validation defects via Veeva Vault and GQTS; oversaw CAPA/CCF management and prepared SOPs, protocols, and validation reports.
Jr. Manager, Microbiology at Dr. Reddy’s Laboratories
June 1, 2013 - June 1, 2018Managed equipment/instrument qualification (BOD incubators, autoclaves, LAF cabinets, heating blocks, pH meters, balances, foggers, BMS); conducted cleanroom validation, cleaning validation, CSV, CQV; delivered end-to-end qualification (FAT, SAT, IQ, OQ, PQ) in GMP-compliant environments; prepared audit responses as SME; supported internal quality audits/regulatory inspections; coordinated training programs and SOPs; performed microbial testing and environmental monitoring; managed media stocks and data handling.
Executive, QC at Virchow Biotech Pvt. Ltd
September 1, 2012 - June 1, 2013Performed microbial identification using VITEK MS; coordinated cross-functional teams for cleanroom environment monitoring; maintained media and stocks; conducted microbial tests (endotoxin, TOC, microbial limit testing) and prepared COAs; participated in regulatory inspections to ensure GxP compliance.
Project Trainee Internship at Mediclone Biotech
January 1, 2012 - July 1, 2012Conducted microbial limit testing; managed microbial media and cultures; analyzed stability samples and supported quality audits/deviation reviews.
Education
Qualifications
Masters in Biotechnology
January 11, 2030 - January 28, 2026Bachelors in Biotechnology
January 11, 2030 - January 28, 2026Lean Six Sigma Yellow Belt
January 11, 2030 - January 28, 2026SAFe Agile for Teams
January 11, 2030 - January 28, 2026ITIL 4 Foundation
January 11, 2030 - January 28, 2026Industry Experience
Life Sciences, Healthcare, Professional Services, Manufacturing, Software & Internet
Experience Level
Intermediate
Intermediate
Intermediate
Intermediate
Hire a QA Engineer
We have the best qa engineer experts on Twine. Hire a qa engineer today.