BA / BE Auditor 2

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 System Demo and further information, please call +91 98100 68241 or mail us at bd@crqa.in