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
Minimum Bachelor of Science (B.S.) in Chemistry, Pharmacy, Biochemistry or related field. A Master of Science (M.S.) in Chemistry, Pharmacy, Biochemistry or related field is desirable.
Knowledge in and review of, but not limited to, the following: Laboratory test procedures, cGMP/cGLP/cGDP requirements, ICH/US FDA guidelines, raw material analyses, method validation guidelines, analytical method transfers, finished products and stability testing procedures; standard operating procedures, general procedures, test procedures, validation protocols; manufacturing and packaging batch records, excipients COAs, packaging components COAs, manufacturing reports, scale-up reports, product development reports; Quality overall summaries, executive summaries
Proficient in MS Office applications (Word, Excel)
Ability to monitor, coordinate and prioritize work in an effective and efficient manner, with capacity to manage simultaneous projects within a set timeline; ability to continuously make an assessment of the work load and suggest any support required on need basis
Must be a self-motivated, proactive team player with positive interaction with colleagues and stakeholders to ensure work ethics, teamwork, and discipline.
Conduct oneself in a professional manner in alignment with corporate values.
Ability to work and interact successfully in a global, diverse and dynamic environment.
Demonstrates excellent interpersonal communication skills: verbal, written and presentation skills.
Excellent project management and problem solving skills
The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).
Experience
Minimum 5 years of experience in a pharmaceutical company within a cGMP environment in Quality Control and/or Analytical R&D department is required.
Minimum 2 years of Quality Assurance exposure in Pharmaceutical industry, involving review of manufacturing/ packaging batch records and investigations is desirable
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