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Data Reviewer

Company: Kaztronix
Location: New Brunswick
Posted on: January 21, 2023

Job Description:

The Data Reviewer for the 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.

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.

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.

Education and Experience:

  • 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).
  • 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

Keywords: Kaztronix, New Brunswick , Data Reviewer, Other , New Brunswick, New Jersey

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