Data Reviewer

2 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 ready for regulatory submission to the US FDA.

Responsibilities include:

  • Reviewing assigned pre-submission applications using department SOPs and exhaustive audit checklists to ensure Data Integrity, Reliability, Accuracy, and Traceability of any submitted data.
  • Ensuring compliance with cGMP/cGLP and good documentation procedure during the review process.
  • Auditing regulatory pre-submission documents from the manufacturing and quality units within the purview of ODR checklist.
  • Communicating any audit comments/observations/findings to respective stakeholders and assessing acceptability/appropriateness of responses.
  • Informing the manager/s and Chief Data Reliability Officer immediately of any critical data integrity issues or data irregularity.
  • Reporting all audit findings in the ODR audit worksheets and highlighting noteworthy/major/critical observations on CDRO certifications.
  • Completing the audit tasks within the specified timeframe without compromising the quality of the audit and archiving all documents in a closed electronic system.
  • Collating audit findings in the audit comments log.
  • Performing any other responsibilities as assigned by the manager/s depending on departmental needs.
  • Completing all training requirements as per Learning Management System (LMS) and as per Safety.
  • Adhering to the Safety and Health Program and associated plans.

Work Conditions:

Corporate office environment.

Laboratory environment – QC and ARD.

Manufacturing/Production environment.

The ODR data reviewer will be mainly working in an office environment as the job requires review of copies of reference documents. Exposure to laboratory/manufacturing environments is at a minimum only and only expected when the ODR data reviewer needs to physically view any concerns or needs to have a face-to-face discussion with the 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 of time, work on the computer for the majority of his/her 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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