Overview
Data Reviewer Jobs in Sandringham, New Brunswick, Canada at SUN PHARMA
Location: Sandringham
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
Title: Data Reviewer
Company: SUN PHARMA
Location: Sandringham, New Brunswick, Canada
Category: Quality Assurance – QA/QC (Data Analyst)
