Srinija A.
Quality Control Chemist
Experience
Quality Control Chemist
Pfizer Inc.
- Conduct analytical testing of drug substances and finished dosage forms using HPLC (Empower 3), GC, FTIR, and UV-Vis to ensure product identity, purity, and assay compliance with USP and ICH specifications.
- Perform stability, dissolution, and impurity testing for clinical and commercial batches, supporting regulatory submissions and ongoing product lifecycle management.
- Lead OOS/OOT investigations by reviewing chromatographic data, identifying root causes, and implementing CAPA, improving accuracy and preventing recurrence of deviations.
- Validate and transfer analytical methods between development and QC laboratories to ensure precision, reproducibility, and compliance with global Pfizer quality standards.
- Maintain analytical batch records, calibration logs, and CoAs following GDP and FDA 21 CFR Part 11 data integrity requirements to ensure full audit traceability.
- Collaborate cross-functionally with QA, Manufacturing, and R&D for analytical troubleshooting, test optimization, and on-time batch release.
- Support internal and FDA inspections by preparing documentation, presenting analytical results, and implementing post-audit improvements to maintain continuous compliance.
Quality Control Chemist
Dr. Reddy’ Laboratories Ltd.
- Performed raw material, in-process, and finished product testing using HPLC, FTIR, UV-Vis, Karl Fischer, and wet chemistry techniques in compliance with cGMP.
- Validated analytical methods and conducted system suitability to verify precision, accuracy, and robustness before sample analysis.
- Investigated OOS/OOT results, documented findings, and implemented CAPA to prevent recurrence and improve process control.
- Executed instrument calibration and maintenance to ensure consistent analytical performance and data accuracy.
- Prepared analytical worksheets, logbooks, and stability reports following GDP and internal quality procedures.
- Collaborated with QA and Production teams to coordinate testing schedules and ensure timely batch release and regulatory compliance.
- Supported successful customer and regulatory audits by maintaining documentation accuracy and responding effectively to observations.
Summary
Quality Control Chemist with 3 years of experience in cGMP-regulated pharmaceutical environments. Proficient in analytical techniques including HPLC (Empower 3), GC, FTIR, UV-Vis, Karl Fischer, TOC, and wet chemistry for testing raw materials, in-process, and finished products. Skilled in OOS/OOT investigations, CAPA implementation, method validation, and equipment qualification (IQ/OQ/PQ) ensuring data accuracy and compliance with FDA and ICH guidelines. Strong command over Good Documentation Practices (GDP), LIMS data management, and audit readiness activities. Recognized for maintaining high laboratory standards, supporting stability and cleaning validation programs, and fostering effective cross-functional collaboration with QA, Manufacturing.
Languages
Education
Sacred Heart University
Master of Science · Health Informatics · Fairfield, United States
Bicol Christian College of Medicine
Doctor of Medicine · Medicine · Naga City, Philippines
Bicol Christian College of Medicine
Bachelor of Science · Psychology · Naga City, Philippines
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