Data Offres d'emploi - Tracadie-Sheila, NB

The Data Reviewer, Office of Data Reliability (ODR) is accountable for critical review of pre-submission applications ready for regulatory submission to the US FDA. Responsibilities include the review of assigned pre-submission applications by using department SOPs and exhaustive audit checklists to ensure Data Integrity, Reliability, Accuracy, and Traceability of any submitted data.

Area Of Responsibility

• Ensures compliance with cGMP / cGLP and good documentation procedure during the review process
• Audits regulatory pre-submission documents from the manufacturing and quality units within the purview of ODR checklist
• Communicates any audit comments / observations / findings to respective stakeholders and assesses acceptability / appropriateness of responses
• Informs the manager / s and Chief Data Reliability Officer immediately of any critical data integrity issues or data irregularity
• Reports all audit finding in the ODR audit worksheets and highlight noteworthy / major / critical observations on CDRO certifications
• Completes the audit tasks within the specified timeframe without compromising the quality of the audit and archives all documents in a closed electronic system
• Collates audit findings in the audit comments log
• Performs any other responsibilities which are required as assigned by the manager / s depending on departmental needs
• Completes all training requirements as per Learning Management System (LMS) and as per Safety
• Adheres 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.

Travel Estimate

Up to 0 %

Education and Job Qualification