Ramajit Lahiri

• Reviewed chromatographic data and electronic audit trails in Chromeleon 7.3.1 for accuracy, completeness, and regulatory compliance.
• Conducted periodic and routine audit trail reviews of standalone laboratory systems (21 CFR Part 11 compliant) to verify secure, traceable, and tamper-evident data handling.
• Supported quality oversight through online data review of chromatographic and instrumental data, facilitating prompt verification and minimizing errors.

Electronic Data & Audit Trail Review of Quality Management & Compliance Oversight Documentation

• Performed electronic data review and audit trail verification in Empower 3 and Chromeleon 7.3.1 for HPLC systems, ensuring compliance with 21 CFR Part 11 and data integrity standards.
• Conducted data reviews across server-based software and standalone instruments, verifying traceability and compliance.
• Utilized Early Warning System (EWS) software for proactive monitoring and review of Empower 3 data.
• Reviewed analytical results and workflows in LIMS platforms (Caliber & LabWare).
• Executed documentation and investigation tracking using the TrackWise Quality Management System.
• Led Quality Management System (QMS) activities in TrackWise including:
  OOS investigations: Review and approval of plans, hypothesis experiment planning, and closure.
  Lab Events: Plan review and QA approval.
  Deviations: Investigation and root cause review, approval, and closure.
  CAPA: Implementation review, approval, and effectiveness checks.
  Change Control: QA review, evaluation, and approval.
  Internal Audit Response handling and compliance tracking.
• Performed QC analytical document review and facilitated batch release via SAP-HANA through LIMS.
• Verified compliance of STPs, specifications, and method validation protocols through SOP gap assessments, review, and approvals.
• Oversaw analytical techniques for raw materials, finished products, and stability samples.
• Supported method validation activities, including protocol review.
• Reviewed sampling checklists for raw materials and packaging materials, and handled sample posting and usage decisions in SAP.
• Conducted routine QC rounds to ensure adherence to GLP and cGMP guidelines.
• Managed responses to CQA audits, including coordination of audit activities and observation closure.
• Participated in ASPIRE cost-reduction projects as part of operational excellence initiatives.

GLP Section & Instrument Calibration Responsibilities

• Worked in the GLP (Good Laboratory Practice) section, ensuring routine laboratory operations adhered to data integrity, safety, and regulatory compliance standards.
• Performed calibration, performance verification, and maintenance of various analytical instruments including:
  HPLC (High-Performance Liquid Chromatography)
  GC (Gas Chromatography)
  KF (Karl Fischer Titrator)
  Coulometer
  FTIR (Fourier Transform Infrared Spectrophotometer)
  Analytical Balances and Micro Balances
• Maintained and reviewed calibration records to ensure accuracy and traceability in accordance with GLP, cGMP, and 21 CFR Part 11 requirements.
• Supported laboratory readiness for internal audits, regulatory inspections, and quality assurance reviews by ensuring all equipment was calibrated and within validated operational limits.

Analytical Testing Responsibilities

• Performed comprehensive analysis of Raw Materials (RM), Finished Products (FP), and Stability samples as per pharmacopeial and in-house specifications.
• Conducted testing using a wide range of techniques, including:
  Water content by Karl Fischer titration (volumetric/coulometric methods)
  Identification (ID) by FTIR spectroscopy
  Common analytical techniques: pH, clarity, color, LOD, ROI etc.
  Chromatographic purity and related substances (RS) testing by HPLC/GC
  Assay determination using validated chromatographic or titrimetric methods
• Ensured all analyses were performed in compliance with GLP, cGMP, ICH guidelines, and data integrity principles.
• Performed assay and related substances (RS) analysis using Gas Chromatography (GC) methods in compliance with pharmacopeial standards and internal SOPs.
• Documented results accurately in LIMS and maintained compliance with regulatory and internal quality standards for batch release and stability reporting.

• Conducted testing of food samples in compliance with FSSAI (Food Safety and Standards Authority of India) regulations, ensuring safety and quality standards were met.
• Performed analysis of drug samples as per Indian Pharmacopoeia (IP) guidelines, including identification, assay, and purity testing.
• Ensured all testing procedures adhered to GLP and cGMP requirements, maintaining accurate documentation and data integrity.
• Coordinated sample handling, testing, and reporting to support regulatory compliance and quality assurance.