QA Manager (R1069102) in Mumbai, India at IQVIA™

Date Posted: 2/6/2020

Job Snapshot

  • Employee Type:
  • Location:
    Mumbai, India
  • Experience:
    Not Specified
  • Date Posted:
  • Job ID:

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

o             Support in development, release and training of Quality documents related to Quality for India

o             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

o             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™

Job ID: R1069102