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Data Integrity Specialist

2 months ago

Fredericton, New Brunswick, Canada SUN PHARMA Full time

SUN PHARMA is seeking a meticulous and detail-oriented Data Reviewer to join our Office of Data Reliability (ODR). This critical role ensures the accuracy, reliability, and integrity of data submitted for regulatory approval to the US FDA.

As a Data Reviewer, you will play a vital part in safeguarding the quality and compliance of our pharmaceutical products. You will meticulously review pre-submission applications using established Standard Operating Procedures (SOPs) and comprehensive audit checklists. Your expertise will guarantee that all submitted data adheres to the highest standards of Data Integrity, Reliability, Accuracy, and Traceability.

Responsibilities:
  • Maintain strict adherence to cGMP/cGLP guidelines and best documentation practices throughout the review process.
  • Conduct thorough audits of regulatory pre-submission documents originating from manufacturing and quality units within ODR's purview, utilizing designated checklists.
  • Communicate audit findings, observations, and comments effectively to relevant stakeholders, evaluating the acceptability and appropriateness of their responses.
  • Promptly inform management and the Chief Data Reliability Officer of any critical data integrity issues or irregularities detected.
  • Document all audit findings meticulously in ODR audit worksheets and highlight significant observations on CDRO certifications.
  • Consistently deliver audit tasks within specified timeframes, upholding exceptional quality standards, and archive all documents securely in a designated electronic system.
  • Compile audit findings into a comprehensive audit comments log.
  • Embrace additional responsibilities as assigned by management to support departmental needs.
  • Complete all mandatory training requirements outlined in the Learning Management System (LMS) and adhere to safety protocols.
  • Uphold the principles of the Safety and Health Program and associated plans.
Work Environment:

The Data Reviewer primarily operates within a corporate office environment, focusing on reviewing reference documents. Limited exposure to laboratory/manufacturing environments may occur for specific purposes, such as addressing concerns or engaging in face-to-face discussions with stakeholders.

Physical Requirements:

This role requires the ability to sit at a desk for extended periods and utilize computer systems for the majority of work hours. Occasional navigation within office, laboratory, and/or production areas may be necessary while adhering to safety protocols. The Data Reviewer must also be prepared to wear appropriate personal protective equipment (PPE) as required in specific locations, including respirators, safety glasses/goggles, and safety shoes.