- Recherche d'emploi
- Miramichi, NB
- electronic technician
Electronic technician Offres d'emploi - Miramichi, NB
Créer une alerte d'emploi pour cette recherche
Electronic technician • miramichi nb
Data Reviewer
SUN PHARMANew Brunswicknail care technician
Quinn NailsMiramichi, NB, CAnail care technician
Kinh NailsMiramichi, NB, CAnail care technician
KJ's Beauty SpaMiramichi, NB, CAHorizon Pharmacy Technician Application
Horizon Health NetworkMiramichiRemediation Technician – Moncton or Saint John
On Side RestorationNew Brunswick, CAadministrative secretary
Wendys restaurantNB, CAEntry-Level Market Researcher (Remote)
FocusGroupPanelGordon, New Brunswick, CanadaCall for Interest
NBCCNew Brunswick, Miramichi, CanadaTechnical Sales Specialist (m / f / d)
Kennametal, Inc.Remote, NB, NLField Sales Representative, Nursing Health Education (Atlantic Canada and Quebec)
Elsevier Canada Inc CompanyHome Based, Canada NBsandwich artist
SubwayMiramichi, NB, CATechnicien(enne) support matériel intégré / Embedded Material Support Technician (Gagetown)
TextronNew Brunswick, New Brunswick, CARecords Management Associate (Bilingual)
Homewood HealthNB, CATechnical Customer Support Specialist
TeleperformanceRemote, NB, CAAdjoint(e) administratif(ve) / de co-paiement bilingue- Opportunités Future / Bilingual Administration & Co-Pay Assistant - Future Opportunities
Innomar StrategiesRemote, NBMaintenance Coordinator
BGISNB, CanadaUXO Technician / Technician Supervisor (22017)
GEMTEC Consulting Engineers & Scientists LimitedAny, New Brunswickadministrative assistant
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