Role Description We are seeking a detail-oriented and scientifically driven GMP Laboratory Analytical Data Reviewer to join our Quality team. The successful candidate will be responsible for performing thorough technical and compliance reviews of laboratory analytical data and supporting documentation to ensure accuracy, completeness, traceability, data integrity, and compliance with GMP requirements.

nKey Responsibilities

nPerform detailed review of analytical laboratory data packages, including raw data, chromatograms, calculations, worksheets, laboratory notebooks, and electronic records.

nReview data generated from analytical techniques such as HPLC/UPLC, GC, UV-Vis, FTIR, dissolution, Karl Fischer, and other laboratory instrumentation, as applicable.

nVerify calculations, system suitability, sample and standard preparation, instrument status, sequence information, integration, and specification compliance.

nEnsure laboratory data comply with GMP/cGMP, SOPs, Positive Documentation Practices (GDP), and ALCOA+ data integrity principles.

nReview electronic data and audit trails using applicable laboratory software and systems such as Empower, LIMS, or equivalent platforms.

nIdentify and document discrepancies, atypical results, OOS/OOT results, documentation deficiencies, and potential data integrity concerns.

nSupport OOS/OOT investigations, deviations, CAPAs, change controls, and laboratory investigations.

nReview stability, release, raw material,



in-process, and finished-product analytical data, as applicable.

nEvaluate data trends and identify recurring laboratory or analytical issues.

nEnsure analytical records are complete, scientifically sound, traceable, and inspection-ready.

nCollaborate with QC Analysts and QA to resolve review comments and compliance issues.

nQualifications

nBachelor's degree or college diploma in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, or a related scientific discipline.

n2–5+ years of experience in a pharmaceutical, biotechnology, contract laboratory, or other GMP-regulated laboratory environment.

nStrong experience with analytical data review and laboratory documentation.

nHands-on knowledge of analytical techniques such as HPLC/UPLC, GC, UV-Vis, FTIR, dissolution, or related instrumentation.

nStrong understanding of GMP/cGMP, GLP, GDP, data integrity, and ALCOA+ principles.

nExperience with chromatography/data systems such as Empower, LIMS, or equivalent is highly desirable.

nExperience with OOS/OOT investigations, deviations, CAPA, stability testing, and/or method validation is an asset.

nStrong analytical thinking, attention to detail, organization, and problem-solving skills.

nExcellent written and verbal communication skills.

nAbility to work independently while collaborating effectively with QC, QA, and other cross-functional teams.

📌 QA Data Reviewer- Remote (Bengaluru)
🏢 Pathogenia Lab
📍 Bengaluru