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QA Manager

3.00 to 4.00 Years   Mumbai City   06 Jul, 2019
IQVIA
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryManagement Consulting / Strategy
Functional AreaQuality (QA-QC)
EmploymentTypeFull-time

Job Description

  • Join us on our exciting journey! IQVIA is The Human Data Science Company , focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.
  • Support in maintenance of country quality system applying to GxP and health-regulated activities related to the development, manufacturing, distribution and commercialization of all products under development
  • Coordinate with a network of professionals involved in GxP and health-regulated activities to accomplish Quality related projects and deliverables.
  • Batch Release process: Support in batch release activities e.g.; in coordination, testing sample arrangement or addressing any queries received for government laboratories. Support follow-up with government laboratories to ensure that the concerned officials receive the documents/file and samples for testing. Support activities to ensure speedy reviews and clearance by the govt laboratory
  • Support in management of third party quality agreements to ensure valid and signed agreements are in place. Ensure that service agreements contain quality dispositions and other mandatory quality related clauses for all subcontractors of GxP and health-regulated activities.
  • Ensure that valid and signed quality agreements are in place between affiliate and imported manufacturing sites, distribution centers for all GxP activities under scope for India and other countries
  • Support in development, release and training of Quality documents related to Quality for India
  • Support in implementing of screening for released global quality documents and local regulations to capture the requirements that must be transcribed into Country Quality documents
  • Organize and manage information sharing, training sessions or programs related to processes owned by the CQH for concerned country associates
  • Country Quality Review
  • Support in conducting annual Affiliate Quality Review to present the outcomes to Country Senior Management Board
  • Support CQH to monitor related Quality Program and Action Plan follow-up
  • Support CQH in managing Quality Risks within the country: alerts and recall
  • We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA
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Keyskills :
salesscreeningoperationsactionprocesstestingmaintenancequeriesmanagementanalyticsqualityagreementsmanufacturingervicedevelopmentcustomerbusiness

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