Nitin Kumar
Senior Auditor-Clinical QA
- Role
- Senior Auditor- Clinical Quality Assurance at Bristol Myers Squibb
- Location
- South Delhi, DL, IN
- LinkedIn followers
- 500 followers
About Nitin Kumar
Post graduate in pharmacy with 20+ years of industrial experience. I have extensive experience in auditing Pharmacovigilance sites, BA/BE locations, software validation documents and establishing compliance monitoring programs. Regulatory handling inspection handling, pre inspection preparation, formulation and tracking of CAPAs are my niche work areas.As a GVP auditor have conducted 175+ audits and faced 25+ GVP inspections
Experience
Senior Auditor- Clinical Quality Assurance
Oct 2025 — Present · Hyderabad, IN
Conduct and report risk‑based GCP audits of clinical trials, vendors, systems and processes to ensure compliance with global regulatory requirementsEvaluate the design and effectiveness of clinical quality systems to safeguard patient safety, data integrity and regulatory adherencePartner with cross‑functional stakeholders to identify quality risks, trends, and systemic gaps, driving proactive and preventive actionsAssess compliance with ICH‑GCP, local and international regulations, company policies and industry best practicesReview and follow up on CAPAs to ensure root cause identification, sustainability, and effectiveness of corrective actionsSupport inspection readiness activities, including regulatory inspection preparation, conduct and responseProvide independent, value‑adding feedback that fosters continuous improvement and quality culture maturityLeverage audit insights to contribute to organizational learning, compliance strategy and quality innovationLead and/or participate in CQA and/or company processes and improvement initiatives as assigned
Education
Jamia hamdard
master in pharmacy , Pharmaceutical Sciences
2002 — 2004
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