Santosh Dixit Email and Phone Number

Global Corporate Quality Assurance

Implemented Regulatory Servilance section as a part of Corporate QA function. Currently leading QMS and Compliance Activity for Discovery &Development QA. Responsible for more than 16 active clients.

Compliance lead for FTO3 &FTO2

Responsible for IPQA and QMS activity of Aurongabad plant. Worked as Validation head for Lupin Visakhapatnam plant(Green field project)

Leading QMS team .

Responsible for all QMS functions like Process Non Conformance (Deviations / Incidents),Material Non Coformance,Change control,Market Ciomplaint, Internal Audit, Quality Review meeting etc.Directly involved in USFDA audit and played a significant role for lifting USFDA warning from Aurobindo pharma ltd, Unit VI

Looking after all QA functions of one block (Block C)i.e QMS functions(Deviations,Change control,Incidents,Complaints etc),Training requirement,IPQA activities etc

Responsible for Exhibit Batches,CPS product and CIP process,Involved as a QA group leader for more than 200 ANDA filing and 5 NDA filling.Involved in new product introduction,Master documents finalization,Batch Execution, and regulatory filing related activities.Directly i was involved with verious MNC Pharmaceutical Customers for Customer Pharmaceutical Projects.

Looking after IPQA activities for solid oral,Liquid injectable and dry powder injection products.

IPQA personnel.