Required Skillset Key Responsibility:
Review and verify analytical data generated from finished product testing activities to ensure accuracy, completeness, and compliance with approved procedures.
Review chromatographic data generated through systems such as Empower, LabSolutions, Chromeleon, etc., including chromatograms, sequences, processing methods, and audit trails.
Ensure data integrity compliance by reviewing raw data, electronic records, audit trails, and supporting documents as per regulatory requirements.
Recalculate and cross-check analytical results against original methodology, approved specifications, protocols, and acceptance criteria.
Review laboratory investigations including Out-of-Specification (OOS), Out-of-Trend (OOT), deviations, laboratory incidents, and CAPA to ensure proper assessment and closure.
Review and approve analytical documents such as test reports, analytical worksheets, protocols, method validation documents, stability study reports, and related records.
Verify instrument calibration records, system suitability results, and equipment qualification documents for compliance.
Ensure analytical activities comply with GMP, GLP, data integrity principles,



and regulatory expectations (USFDA, EMA, MHRA, etc.).
Participate in internal and external audits and provide necessary support during regulatory inspections.
Collaborate with QC, Analytical Development, QA, Formulation, and Regulatory teams for investigation and compliance-related activities.
Identify gaps, recommend corrective actions, and support continuous improvement initiatives within analytical operations.

Required Skillset:
Robust knowledge of analytical chemistry principles and pharmaceutical testing procedures.
Valuable understanding of HPLC/UHPLC/GC data review and chromatographic evaluation.
Hands-on experience with chromatography data systems (CDS) such as Empower, LabSolutions, or Chromeleon.
Sound knowledge of GMP, GLP, data integrity requirements (ALCOA+), and regulatory guidelines.
Experience in reviewing method validation, stability, and analytical documentation.
Ability to critically analyze data, identify discrepancies, and make compliance-based decisions.
Valuable communication, documentation, and report review skills.

📌 Reviewer Analytical R&d Dept , Tamil Nadu (India)
🏢 Theragen Lifesciences
📍 India