Experienced clinical research and quality assurance specialist with 6+ years in bioequivalence trials, clinical trials, and regulatory compliance. Proficient in GCP, GMP, GLP, and QMS, with a strong background in audit management, vendor oversight, regulatory inspections, and compliance with FDA, EMA, and ICH-GCP guidelines. Adept at SOP development, risk-based auditing, CAPA execution, and process optimization, ensuring data integrity and operational excellence in clinical research.
Core Competencies
Regulatory Compliance & Inspection Readiness
Clinical Quality & Risk Management
Audit Strategy & Governance
CAPA & Deviation Governance
Clinical Trial Oversight
Vendor & CRO Management
Data Governance & Compliance
Leadership & Cross-Functional Collaboration
Professional Experience
Ipca Laboratories Ltd. – Assistant Manager
Sep 2022 – Aug 2024 | Mumbai, India
Led cross-functional teams ensuring compliance with ICH-GCP, FDA, EMA regulations.
Managed QMS implementation and regulatory inspections with zero critical findings.
Synergen Bio & Panexcell Clinical Labs
Feb 2022 – Sep 2022 | Pune & Mumbai, India
Executed audits and CAPAs across clinical and bioanalytical domains.
Maintained regulatory compliance and process improvements across functions.
Genechth Research Pvt. Ltd. – Sr. Executive QA
Sep 2021 – Jan 2022 | Mumbai, India
Led QMS system implementation and CRO oversight.
Managed regulatory submissions and inspection readiness for DCGI.
Lotus Labs – Bioanalytical Officer
Sep 2017 – Dec 2018 | Bangalore, India
Performed bioanalytical validations and participated in regulatory audits.
Certifications & Training
ICH-GCP
ISO 13485:2016 Medical Devices QMS
ISO 14971:2019 Risk Management
Lead Auditor Course
Team Building, Business Communication
Get in Touch
For collaboration or project inquiries, feel free to contact me.
