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