Sunita Nawale

Sunita Nawale

Assistant Manager, Clinical Quality Assurance

Galway, Ireland | Indian National

sunitanavale2@gmail.com Download CV

About

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

Get in Touch

For collaboration or project inquiries, feel free to contact me.

Email Me