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Safety health manager Jobs in Bathurst, NB
Data Reviewer
SUN PHARMANew BrunswickLead Carpenter
ServiceMaster RestoreBathurst, New Brunswick, CA- Promoted
Electrical Division Manager
Electro Federation CanadaBathurst, Gloucester County, CanadaClerk Administration
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Blue ShockNew BrunswickInsurance Advisor Life, Health & Wealth
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General Manager
Steele Auto GroupNB, Canada- Promoted
Virtual Family Physician - Atlantic License (Bilingual French - remote role)
Teladoc HealthNew Brunswick, Canada- Promoted
- New!
Sales Account Manager
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EllisDona, NB, CAhealth care aide
Southern Comfort Villa ResidenceBathurst, NB, CAGeneral Labourer Bathurst
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Area Sales Manager
Deep Sea Electronics LtdNew Brunswick, Canada, CanadaMaintenance Superintendent – Mechanical
Halliwell ConsultingNew Brunswick, CAStore Manager
Meridia Recruitment SolutionsNew Brunswick1.0 JP Mental Health
York Region District School BoardNew Brunswick, Canada- Promoted
MarketingCommunications Manager
destinationone ConsultingBathurst, New Brunswick, CanadaAssistant - Community Health
Canadian Red CrossCAN - NB - Bathurst District OfficeService & Maintenance Technician- Fire Safety (Evening Shift)
OlymbecVille Saint-Laurent, QC, CA- Promoted
HSEC Coordinator, Heath Steele Mine
Glencore cuivre Amérique du NordNew Brunswick, Canada, CanadaData Reviewer
SUN PHARMANew Brunswick- Full-time
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