Sunilkumar Adupa

GCP Quality & Compliance Specialist with 12+ years of experience supporting global clinical trials, sterile manufacturing across Pharma, Biotech, and CRO environments. Proven expertise in quality oversight for clinical programs, RACT implementation, deviation/CAPA governance, data integrity, serious breach/privacy management, and inspection readiness (USFDA, MHRA, BIMO, WHO, CDSCO, TGA). Experienced in protocol quality review, risk-based GCP audits, vendor quality oversight, quality metrics trending, and advanced quality analytics.

Operational Compliance Specialist- II (Compliance Lead for Client Projects) - Imaging Endpoints Pvt. Ltd. - Hyderabad, India

(2022-01)

• Provided independent GCP quality oversight across 12+ global clinical trial programs.
• Ensured RACT completion and quality review for assigned trials.
• Supported Clinical Trial Teams with deviation management, CAPA, serious breaches, privacy issues, and inspection readiness.
• Delivered data integrity oversight for imaging-based endpoints and biomarker technologies.
• Participated in clinical protocol review and identification of critical data & processes.
• Managed quality metrics & dashboards, identified trends, and implemented corrective actions.
• Supported sponsor audits and regulatory inspections.
• Oversaw study-specific vendor quality performance.

Assistant Manager- QA for Sterile Dry power, Injections and Lyo - Amneal Pharmaceuticals Pvt. Ltd. - Hyderabad, India

(2020-08 - 2021-12)

• Led CAPA, deviation, and change control processes, ensuring timely closure and documentation compliance.
• Coordinated regulatory inspections (USFDA, WHO, CDSCO) and provided SME support during audits.
• Prepared Excel-based KPI dashboards to monitor deviation timelines, CAPA effectiveness, and compliance gaps.
• Contributed to continuous improvement initiatives, strengthening QMS and audit readiness.

Senior Executive (Quality Assurance) - Sanofi Healthcare India Pvt. Ltd. - Hyderabad, India

(2018-01 - 2020-07)

• Supported GxP inspections across R&D and manufacturing.
• Conducted risk assessments and deviation reviews.
• Led Phenix QMS activities for CAPA and deviation lifecycle.
• Delivered training on inspection readiness and data integrity.

Sr. Officer (QA- Audit & Compliance and Site Lead for Risk Management) - Mylan Laboratories Pvt. Limited - Bangalore, India

(2016-07 - 2017-12)

• Conducted risk-based audits and prepared responses to findings.
• Led site risk management and systemic trending.
• Supported vendor qualification and oversight.

Management Staff (QA- C&Q- Sterile Validation Projects) - CIPLA Ltd - Indore, India

(2015-01 - 2016-07)

• Conducted compliance reviews and validation oversight for sterile projects.
• Ensured adherence to regulatory documentation and supported CSV compliance.

Trainee chemist (QA- C&Q- Sterile Validation Projects) - Gland Pharma Limited - Hyderabad, India

(2013-06 - 2014-12)

• Performed compliance audits and QA documentation reviews for regulatory submissions.

Master of Pharmacy - Pharmaceutical Analysis & QA - Vikas College of Pharmaceutical Sciences - JNTU (2013)