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R&D Quality Operations Test Method Validation

2.00 to 5.00 Years   Chennai   04 Aug, 2019
PFIZER LIMITED
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaR&D / Product Design
EmploymentTypeFull-time

Job Description

  • Quality review of test method validation and transfer protocols / reports to ensure requirements are met and work with laboratory personnel to resolve the issues, if any
  • Evaluate impact on changes proposed on test methods and initiate and or participate in Quality Risk Assessment activities.
  • Conduct periodic Internal audits and ensure corrective actions are completed within stipulated timeline.
  • Provide support during internal and external audits and ensure all corrective actions are addressed.
  • Perform regular review of electronic notebook and audit trails as part data integrity compliance.
  • Participate in or lead analytical related quality investigations.
  • Sustain a culture of quality and safety within the R&D organization
  • Recognize compliance issues and develop and communicate resolutions to the issues.
  • Leads / participates in various projects in support of organizational strategy and priorities
  • Providing guidance to the R&D analyst and the development team on requirements for test method validation and tech transfer and maintaining the required documentation per regulations.
  • Develop cGMP continuous improvement initiatives and communicate these to all levels of the organization.
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Keyskills :
techtransferinternalauditexternalauditdataintegrityriskassessmentmethodvalidationqualemploymentopptunityrectiveactions

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