Data Reviewer

4 weeks ago

Fredericton, New Brunswick, Canada SUN PHARMA Full time
Job Title: Data Reviewer

The Data Reviewer plays a critical role in ensuring the accuracy and reliability of pre-submission applications ready for regulatory submission to the US FDA.

Responsibilities:
  • Conduct thorough reviews of assigned pre-submission applications using department SOPs and exhaustive audit checklists to ensure Data Integrity, Reliability, Accuracy, and Traceability of submitted data.
  • Ensure compliance with cGMP/cGLP and good documentation procedures during the review process.
  • Audit regulatory pre-submission documents from manufacturing and quality units within the purview of ODR checklists.
  • Communicate audit comments, observations, and findings to stakeholders and assess the acceptability of responses.
  • Inform the manager and Chief Data Reliability Officer of critical data integrity issues or data irregularities.
  • Report audit findings in ODR audit worksheets and highlight noteworthy observations on CDRO certifications.
  • Complete audit tasks within specified timeframes without compromising quality and archive documents in a closed electronic system.
  • Collate audit findings in the audit comments log.
  • Perform other responsibilities as assigned by the manager depending on departmental needs.
  • Complete all training requirements as per Learning Management System (LMS) and Safety.
  • Adhere to the Safety and Health Program and associated plans.
Work Environment:

The Data Reviewer will primarily work in a corporate office environment, with occasional exposure to laboratory and manufacturing environments.

Physical Requirements:

The physical demands of this role include sitting for long periods, working on a computer, and navigating office, lab, and plant floor environments while adhering to safety protocols.

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