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- Edmundston, NB
- data collection
Data collection Offres d'emploi - Edmundston, NB
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Data collection • edmundston nb
Data Reviewer
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PARRASHINE HOME DECORNB, CAData Reviewer
SUN PHARMANew BrunswickThe 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