Data Reviewer

Responsibilities

• Perform critical review of pre-submission applications to ensure data integrity, reliability, accuracy, and traceability for US FDA regulatory submissions.
• Audit regulatory documents from manufacturing and quality units using established SOPs and exhaustive audit checklists.
• Ensure strict compliance with cGMP, cGLP, and cGDP requirements and good documentation procedures.
• Communicate audit findings, observations, and comments to stakeholders and assess the appropriateness of their responses.
• Immediately escalate critical data integrity issues or irregularities to management and the Chief Data Reliability Officer.
• Document all findings in ODR audit worksheets and maintain audit comments logs.
• Complete all assigned audit tasks within specified timeframes while maintaining high quality and archiving documents in closed electronic systems.

Requirements

• Bachelor of Science (B.S.) in Chemistry, Pharmacy, Biochemistry, or a related field.
• Minimum of 5 years of experience in a pharmaceutical company within a cGMP environment, specifically in Quality Control and/or Analytical R&D.
• Strong knowledge of cGMP/cGLP/cGDP requirements, ICH/US FDA guidelines, and laboratory test procedures.
• Proficiency in MS Office applications, specifically Word and Excel.
• Intermediate English language proficiency (CEFR B1 level or higher).
• Excellent interpersonal, verbal, and written communication skills.
• Ability to manage simultaneous projects and prioritize workload effectively in a dynamic environment.

Preferred Qualifications

• Master of Science (M.S.) in Chemistry, Pharmacy, Biochemistry, or a related field.
• Minimum of 2 years of Quality Assurance exposure in the pharmaceutical industry, including the review of manufacturing/packaging batch records and investigations.

About the Company

Ranbaxy Inc. (USA), a part of Sun Pharmaceutical Industries Ltd, is a leading player in the pharmaceutical industry dedicated to providing high-quality medicines and maintaining the highest standards of data reliability and regulatory compliance.