Experience

• 

  Ranbaxy

  Nov 1989 - Mar 1999

  Supervisor quality assurance

  Various functions of QC/QA/ RA

• 

  Dr. reddy's laboratories

  May 1999 - Jan 2002

  QA/QC/RA functions of assigned unit Resource management and execution of QC / QA / regulatory function at the assigned unit.

  • Manager QC

    Jan 2000 - Jan 2002

  • Asst. Manager QC

    May 1999 - Jan 2000
• 

  Aurobindo pharma

  Jan 2002 - Sept 2002

  Senior manager qa/qc

  Head been working as functional head of QA/QC. Responsible for resource management and implementaion of over all quality systems as per regulatory (US-FDA, TGA,EDQM, MHRA) requirements.

• 

  Cadila pharmaceuticals

  Sept 2002 - Mar 2005

  Strategic planning, structuring and set up of quality systems according to regulatory( US FDA, MHRA, EDQM/ EMA,TGA,MCC, WHO GMP/ GLP) requirements, submission of Drug master files. applications for marketing authorization, Response to regulatory queries / audits. Handling of customer audits. Direct strategic planning and the development of goals, objective and policies according to current regulatory / customer requirements. Determine group structure and ensure development of talent for leadership. Support enhancement of management controls and the entire quality systems.

  • Head ( DGM) quality and regulatory affairs.

    Sept 2003 - Mar 2005

  • Head (A GM) regulatry affairs

    Sept 2002 - Sept 2003
• 

  Jubilant life sciences ltd

  Apr 2005 - Sept 2006

  Head ( gm) regulatory affairs and compliances

  Regulatroy Guidance on development projects. Planning, execution and control of quality compliances.Handling regulatory and customer audits. Timely submission of DMFs and response to regulatory/ customer queries.

• 

  Glenmark pharmaceuticals

  Sept 2006 - Jul 2007

  Vice president quality

  Resource management to execute QA QC functions. Review of DMFs. Response to national and international regulatory/ customer querries. Structuring and implementation of national and international quality policies according to national and international drug regulatory requirements.

• 

  Hiran orgochem ltd.

  May 2008 - Mar 2009

  Vice president qc,qa, & regulatory affairs

  . Resource management and Facilitation for timely submission of drug master files and response to regulatory as well as customer queries.. Defining, structuring, and set up of quality policies according to national and international drug regulatory requirements.

• 

  Jubilant life sciences ltd

  Apr 2009 - now

  A. v. p.- quality

  Regulatory guidance on development projects. Planning, excution and overall control of entire quality activities. Handling regulatory / customer audits.

• 

  Avmk consortium

  Apr 2015 - now

  Director

  AVMK Consortium is a fast growing and rapidly expanding cGMP and ISO consulting agency. The agency has acquired intense knowledge in GMP, GLP, CSV/ part 11, data and document auditing, SOP and regulatory writings, remediation assistance and site training. We offer quality assurance services to our clients to help them gauge their inspection readiness: