Data Reviewer

SUN PHARMANew Brunswick

30+ days ago

Salary

CA$19.50 hourly

Job description

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.

In performance of his / her tasks, the ODR data reviewer should have the ability to sit at his / her desk for long periods of time, work on the computer for the majority of his / her work hours.

If needed, he / she must have the ability to navigate office, lab, and / or plant floor working environments while adhering to safety protocols.

He / she must have the ability to wear applicable personal protective equipment utilized at the site, as required in a specific location / section of the plant, including but not limited to respirators, safety glasses / goggles, and safety shoes.

Travel Estimate

Up to 0 %

Education and Job Qualification

Create a job alert for this search

Data Data • New Brunswick