Data Reviewer

4 weeks ago

Fredericton, New Brunswick, Canada SUN PHARMA Full time

The Data Reviewer, Office of Data Reliability (ODR), plays a critical role in ensuring the accuracy and reliability of pre-submission applications to the US FDA. Key responsibilities include reviewing assigned pre-submission applications using department SOPs and exhaustive audit checklists to guarantee Data Integrity, Reliability, Accuracy, and Traceability of submitted data.

Key Responsibilities:

  • 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 ODR checklist.
  • Communicate audit comments/observations/findings to stakeholders and assess acceptability/appropriateness of responses.
  • Inform the manager/s and Chief Data Reliability Officer immediately of critical data integrity issues or data irregularities.
  • Report all audit findings in the ODR audit worksheets and highlight noteworthy/major/critical 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 assigned by the manager/s 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:

Corporate office environment

Laboratory environment – QC and ARD

Manufacturing/Production environment

The ODR data reviewer will primarily work in an office environment, reviewing copies of reference documents. Exposure to laboratory/manufacturing environments is minimal and only expected when reviewing concerns or having face-to-face discussions with stakeholders.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

  • In performance of his/her tasks, the ODR data reviewer should have the ability to sit at his/her desk for long periods, work on the computer for the majority of work hours.
  • If needed, he/she must have the ability to navigate office, lab, and/or plant floor working environments while adhering to safety protocols.
  • He/she must have the ability to wear applicable personal protective equipment utilized at the site, as required in a specific location/section of the plant, including but not limited to respirators, safety glasses/goggles, and safety shoes.

Travel Estimate:

Up to 0%

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