Dr. Raghavendra Pai, M Pharm, Ph.D

Experience

• 

  Intas Pharmaceuticals

  Nov 2002 - Dec 2006

  Scientific Officer

  Post Marketing surveillance(Phase-4) and Marketing.

• 

  Manipal Acunova

  Jan 2007 - Mar 2014

  *Perform GCP & GLP compliance audits, guide the team for smart auditing & develop leadership qualities in auditors including stress management & time management skills.*Lead and mentor the team of Quality Assurance for overall QA activities, Report to Management, Induction of New Employees and Training of new staff on various regulatory requirements.*Responsible for handling and managing successfully USFDA, WHO DCGI, NABL, CAP and ISO audits/ inspections.*Ensure that studies are conducted as per the regulatory requirements like Schedule-Y, ICH-GCP.*Ensure that studies conducted as per the regulatory requirement of country of submission like USFDA, WHO, EMEA (EU), TGA, Health Canada and AFSSAPS (Germany).*Investigation of nonconfirmities. Show less *Perform GCP & GLP compliance audits, guide & mentor the team of auditors for effective auditing & develop their auditing skills.*Lead the Team of Quality Assurance and manage the overall QA activities, Report to Management, Induction of New Employees and Training of new staff on various regulatory requirements.*Responsible for handling and managing successfully USFDA, WHO DCGI, NABL, CAP and ISO audits/ inspections.*Ensure that studies are conducted as per the regulatory requirements like Schedule-Y, ICH-GCP.*Ensure that studies conducted as per the regulatory requirement of country of submission like USFDA, WHO, EMEA (EU), TGA, Health Canada and AFSSAPS (Germany).*Handle the Regulatory and sponsor queries successfully Show less GCP/GLP audits of Clinical studies, Develop and review SOPs, Preparedness for Regulatory, external audits & timely closure of audit observations.Preparation, control and maintenance of SOPs, Process documents, for BA/BE and Clinical Testing Laboratory.Project/study specific documentation review and regulatory compliance assessment (online/retrospective).Review, control and issue of study and project related documents.Bioanalytical data review starting from method validation to final study sample analysis report.Support and manage quality initiatives viz: ISO 9001:2000, ISO 27001, Six Sigma and other organization wide initiatives.Conducting Internal Quality Audits (IQA) Show less *In-process and retrospective GCP compliance audits for clinical studies.*Documentation and maintenance of SOPs, Process documents for BA/BE and Phase 1 facility*Support and manage quality initiatives viz: ISO 9001:2000, ISO 27001, Six Sigma and other organization wide initiatives.*Quality Assurance activity for BA/BE & Phase 1 studies (Clinical, Analytical and Clinical testing laboratory)*Preparedness for External Audits & timely closure of audit observations*Review of Clinical study protocols, Clinical Study Reports*Staff Training*Quality check of raw data and correspondence with auditors*SOP preparation, review and implementation*Conducting Internal Quality Audits (IQA) Show less

  • Associate Manager-Quality Assurance

    May 2012 - Mar 2014

  • Team Lead-QA

    May 2010 - Apr 2012

  • Sr.Quality Assurance Associate

    May 2009 - May 2010

  • Quality Assurance Associate.

    Jan 2007 - Apr 2009
• 

  Ecron Acunova

  May 2014 - May 2016

  Manager-Quality Assurance
• 

  Norwich Clinical Services - NCS

  Jun 2016 - now

  Oversee Quality Assurance activities of all the functional units(Clinical, Bioanalytical, PV, CT, GLP validations)

  • Head-Quality Assurance

    Nov 2017 - now

  • Senior Manager Quality Assurance

    Jun 2016 - Oct 2017