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QC Auditor II

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QC Auditor II in Kochi-Kerala new

  • GlaxoSmithkline
  • Full time
  • Email
  • Kochi-Kerala
  • 2024/05/04
  • Report

Responsible for reviewing clinical protocols, clinical study reports, publications, written summaries, amendments, narratives, appendices, and pharmacokinetic reports for accuracy and consistency and provides review comments and documentation to the Writer. In addition, proficient in reviewing high-complexity and data-rich documents Ensures consistency and accuracy of all regulatory documents such as written summaries, clinical study reports, protocols, amendments, narratives, pharmacokinetic reports, publications, and appendices to source documents, regulatory agency guidelines, and client requirements. Collaborates with writers to discuss discrepancies, omissions, and errors. Participates in staff meetings, client meetings, and project team update meetings as appropriate. Assists in team reviews. Creates or maintains job aids and completes applicable review checklists. Proficient in reviewing the accuracy and consistency of high‑complexity and data‑rich documents; e.g., documents based on a trial featuring multiple criteria for evaluation, numerous unique cohorts of subjects, and/or a multitude of differing endpoints. Performs other duties as assigned by Manager or Supervisor Labcorp is proud to be an Equal Opportunity Employer: As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status. For more information about how we collect and store your personal data, please see our Privacy Statement.



GlaxoSmithkline

Our?Pharmaceuticals business?has a broad portfolio of innovative and established medicines in respiratory, HIV, immuno-inflammation and oncology. We are strengthening our R&D pipeline through a focus on immunology, human genetics and advanced technologies to help us deliver transformational new medi...

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