Data Integrity Specialist

2 weeks ago

Fredericton, New Brunswick, Canada SUN PHARMA Full time

The Data Integrity Specialist, part of SUN PHARMA’s Office of Data Reliability (ODR), ensures the accuracy and reliability of pre-submission applications for the US FDA. Key responsibilities include reviewing assigned applications using departmental SOPs and exhaustive audit checklists to guarantee Data Integrity, Reliability, Accuracy, and Traceability of submitted data.

Accountabilities:

  1. Ensures compliance with cGMP/cGLP and good documentation practice during the review process.
  2. Audits regulatory pre-submission documents from the manufacturing and quality units within the ODR checklist scope.
  3. Communicates audit comments/observations/findings to relevant stakeholders and assesses the acceptability/appropriateness of responses.
  4. Notifies the manager/chief data reliability officer immediately of any critical data integrity issues or data irregularities.
  5. Reports all audit findings in the ODR audit worksheets and highlights noteworthy/major/critical observations on CDRO certifications.
  6. Completes audit tasks within the specified timeframe without compromising quality and archives all documents in a closed electronic system.
  7. Collates audit findings in the audit comments log.
  8. Performs other responsibilities assigned by the manager depending on departmental needs.
  9. Completes all training requirements as per the Learning Management System (LMS) and Safety.
  10. Adheres 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 Integrity Specialist will primarily work in an office environment, reviewing copies of reference documents. Exposure to laboratory/manufacturing environments is minimal and only required when physically verifying concerns or engaging in face-to-face discussions with stakeholders.

Physical Requirements:

The physical demands described are representative of those required to perform the essential functions of this role.

  1. The Data Integrity Specialist must be able to sit at their desk for extended periods, working on the computer for the majority of their work hours.
  2. They must be able to navigate office, lab, and/or plant floor working environments while adhering to safety protocols.
  3. They must be able to wear applicable personal protective equipment as required in specific locations/sections of the plant, including respirators, safety glasses/goggles, and safety shoes.

Travel Estimate:

Up to 0 %

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