Shrutika Dhawale
eTMF specialist |Product complaint management Veeva Vault RAVE | Bioconnect| medical devices.
- Role
- Senior Process Associate at Tata Consultancy Services
- Location
- Pune, IN
- LinkedIn followers
- 500 followers
Experience
Senior Process Associate
Feb 2023 — Present · Pune, IN
eTMF Document Management :Experienced in managing end-to-end eTMF processes including document classification, indexing, metadata verification, crosslinking, and quality control. Proficient in tools like Veeva Vault, RIM, RAVE Clinical, and Bioconnect.Strong understanding of ICH-GCP, Indian GCP, and regulatory compliance standards. Skilled in resolving TMF content issues, coordinating with TMF Leads and project teams, and maintaining audit-ready documentation. Recognized with performance awards for quality, consistency, and contribution to audit preparedness.Perform Intake and Triaging of commercial and clinical product quality complaints received from patients, regulatory authorities, and business partners. Ensuring all the process is done as per SOP and WI prior to reassignment.
Education
Modern Education Society's Nowrosjee Wadia College Arts, Science, Pune 01
Msc chemistry , Analytical Chemistry
MKSSS Cummins College of Engineering for Women
Bachelor of Science - Bsc, Chemistry
2016 — 2018
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.