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.
