Shivani Kumbhar
Quality Assurance Executive_4 years in CRO_GCP_Audits_Complaince.
- Role
- Quality Assurance Executive at Innvocept Global Solutions
- Location
- Thane, MH, IN
- LinkedIn followers
- 500 followers
About Shivani Kumbhar
Quality Assurance Executive with 4years of experience in a CRO environment. I have worked on GCP based documentation, GCP complaince, SOP review management and audit preparation,deviation CAPA, and internal/external audits and hosted clients audits.
Experience
Quality Assurance Executive
Feb 2024 — Present · Thane, IN
Quality Assurance & RegulatoryEnsure compliance with SOPs, ICH-GCP, and regulatory guidelinesMaintain QMS, SOPs, CAPA, training, and controlled documentsConduct internal, external, vendor, site, and TMF auditsSupport client, sponsor, and regulatory inspectionsReview TMF and study/site files for complianceProvide QA guidance to cross-functional teamsRegulatory ExperienceCRO & clinical trial registration with CTRICTRI study updates, tracking, and compliance checks
Education
Krishna Vishwa Vidyapeeth "Deemed to be University"
Bachelor of Pharmacy - BPharm, Pharmacy
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