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bd@crqa.in

GxP - GCP / GMP / GLP Auditor

QA Director

Has rich experience of 20+ years in pharmaceutical industry / institutes; this includes 15+ years of QA experience in Dr. Reddy’s Laboratories; Jubilant Clinsys& Dabur Research Foundation. An approved analytical chemist from Uttar Pradesh Drug Authority; registered QA personnel from SQA; and also trained Pharmacovigilance personnel – by Indian Pharmacopoeia Commission; Ministry of Health and Family Welfare, Govt. of India. Experience includes QA of all stages of Drug Lifecycle - GMP, GLP & GCP.

As QA personnel has been involved in:

  • Conducting Audits – Internal and External audits, Planning and Facilitating sponsor audits, Regulatory Inspections etc.
  • Developing and Reviewing SOPs
  • Conducting Training sessions
  • Designing and setting of QA systems

Wide range of Clinical QA Experience includes:

  • Investigator Site Audits
  • System Audits: Investigational product storage and distribution; Archiving etc.
  • Phase I-IV clinical trials; Bioavailability (BA/BE), preclinical audits
  • Facility Audits (GCP & GLP)
  • TMF Audit
  • Database Audit
  • TLG Audit
  • Vendor Audits
  • Sponsor Audits
  • Regulatory Audits
  • IB review; CTD review; SP review
  • CSR Audit
For more information on our services, please contact us +91 98100 68241 or mail @ bd@crqa.in
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