Prerna Bharekar

Performed end-to-end validation and remediation of computerized systems, authored SLC documentation (URS, FRS, DS, IQ/OQ/PQ, TM, VSR) and created SOPs, policies and procedures to support a new pharma company setup; validated a medical device SaMD project and led CAPA remediation activities.

Validated Scitara DLX SaaS including risk assessments, threat modelling, VAPT, infra qualification and IOQ, prepared release documentation and white paper, and delivered internal validation training while coordinating cross-functional QA and external application qualifications.

Led end-to-end CSV for multiple regulated applications (LIMS, Trackwise, Veeva, SAP integrations), authored and approved validation deliverables (MVP, IQ/OQ/PQ, RTM, VSR), managed onshore-offshore teams and reduced compliance risks through audits and documentation improvements.

Executed CSV testing and traceability activities for Gilead, prepared and reviewed test protocols, RTMs and test summary reports, and ensured compliance with 21 CFR Part 11 and GxP requirements.

Reviewed and approved system life cycle documents (UD, FS, DD, OQ, PQ), managed change control and deviation reporting, produced monthly compliance reports and trained teams on validation document quality and GDP requirements for Novartis projects.

Completed a Master of Computer Science degree awarded in 2012.

Completed a Bachelor of Computer Science degree awarded in 2009.