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 summariesProficient 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 basisMust 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 skillsThe 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