Data Reviewer

3 weeks ago

Fredericton, New Brunswick, Canada SUN PHARMA Full time

The Data Reviewer role at SUN PHARMA is a critical position that ensures the accuracy and reliability of pre-submission applications ready for regulatory submission to the US FDA.

Key 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 any submitted data.
  • Ensure compliance with cGMP/cGLP and good documentation procedure during the review process.
  • Audit regulatory pre-submission documents from the manufacturing and quality units within the purview of ODR checklist.
  • Communicate any audit comments/observations/findings to respective stakeholders and assess the acceptability/appropriateness of responses.
  • Inform the manager/s and Chief Data Reliability Officer immediately of any critical data integrity issues or data irregularity.
  • Report all audit findings in the ODR audit worksheets and highlight noteworthy/major/critical observations on CDRO certifications.
  • Complete the audit tasks within the specified timeframe without compromising the quality of the audit and archive all documents in a closed electronic system.
  • Collate audit findings in the audit comments log.
  • Perform any other responsibilities as assigned by the manager/s depending on departmental needs.
  • Complete all training requirements as per Learning Management System (LMS) and as per 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/ manufacturing environments when necessary.

Physical Requirements:

The physical demands of this role include the ability to sit at a desk for long periods, work on a computer for the majority of work hours, and navigate office, lab, and/or plant floor working environments while adhering to safety protocols.

Travel Estimate:

Up to 0%

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