Rampriya Uthayakumar

Accomplished Senior Quality Professional specializing in stability programs, reference standard qualification, and process analytical chemistry within cGMP environments. Expertise includes HPLC/prep HPLC, stability lifecycle management, and ICH-compliant practices. Skilled in stability data analysis, OOS investigations, and achieving audit-ready outcomes through effective cross-functional collaboration.

• Led a team of 10 analysts overseeing reference standard qualification and stability programs, ensuring cGMP compliance and alignment with global regulatory expectations.
• Managed end-to-end lifecycle of reference standards, including qualification, requalification, documentation control, and inventory management, supporting stability testing and analytical operations.
• Directed stability studies, including sample management, protocol execution, and coordination with QC labs for testing under ICH conditions.
• Performed stability data review and trend analysis, identifying OOS/OOT results and leading investigations with CAPA implementation.
• Collaborated cross-functionally with QC, QA, Manufacturing, and Regulatory teams to support stability commitments, method validation, and regulatory submissions.
• Contributed to Annual Product Reviews (APR) by compiling and evaluating stability data to ensure product quality and compliance.
• Authored and reviewed qualification and stability-related protocols and reports, ensuring audit readiness and alignment with regulatory requirements.
• Drove timely execution of multiple time-sensitive activities, meeting project timelines and supporting successful regulatory inspections.
• Mentored and developed team members, strengthening technical expertise in stability and reference standard qualification.
• Led instrument qualification programs from URS to release, including PM and calibration scheduling, SOP preparation, and validation planning.
• Spearheaded method development and impurity characterization using RP-HPLC, NP-HPLC, Chiral HPLC, GC, LCMS/MS, and Ion Chromatography.
• Developed analytical methods using UV, PDA, CAD, RI, ELSD detectors for APIs and intermediates; performed method validation and reaction monitoring.
• ISO 9001 trained and certified Internal Auditor, reviewing analytical documentation and ensuring compliance.

• Nitrite Quantification Method: Critical quantification of Nitrite and Nitrate in HCl samples using Ion Chromatography (0.5 PPM level), Developed and optimized the IC method for the precise quantification of nitrite and nitrate in hydrochloric acid (HCl) samples using Ion Chromatography.
• CAD Method development: Developed an HPLC-CAD method to separate multiple peaks, including those with similar molecular weights and non-chromophoric properties, in the analysis of mPEG-NH2-10K. This method enables the identification of critical factors that could impact product quality.
• Innovative Preparative Method: Developed an innovative preparative HPLC Method and scaling up of an impurity (0.1%) to obtain a required quantity in the shortest time and achieved the purity of 99.9%.
• Instrument Qualification: Developed and executed qualification protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), ensuring accurate and reliable instrument performance. Trained team members on qualification processes, regulatory requirements, and documentation procedures, ensuring team adherence to best practices.

• Ion Chromatography Day Workshop by Thermo fisher
• ISO 9001:2015 -Internal Auditors Training by Choda Certification.
• Regulatory requirement for GLP, GCP, and GMP work by Pharma training institute.
• Orientation Workshop on Biologics by CSIR-CCMB, Hyderabad.
• Workshop on QbD and Its Applications using Minitab by IACET.
• Education course on Impurities in DP & DS- A USP Approach by USP Education.
• High resolution Mass spectrometry hands on practice by Waters.