Empower – Waters

Detail-oriented and results-driven QC Chemist with 6+ years of experience in pharmaceutical quality control, specializing in HPLC and GC analysis, method verification, and strict adherence to GMP, GLP, and ICH guidelines (Q2, Q7, Q10). Proven expertise in raw material, in-process, and finished product testing, stability studies, and holding time and sample integrity evaluation. Strong background in data integrity compliance (ALCOA+ principles), OOS/OOT investigations, method validation and transfer, and regulatory documentation including SOPs, COAs, and audit readiness. Recognized for maintaining high standards of laboratory compliance, improving operational efficiency, and supporting successful regulatory inspections.
Analytical Techniques: HPLC, GC, UV-Vis, spectroscopy
Regulatory Compliance: GMP, GLP, ICH Q2, Q7, Q10, FDA, WHO
Data Integrity: ALCOA Principles, 21 CFR Part 11, Audit Trail Review
Quality Systems: OOS/OOT Investigations, Deviations, CAPA, Change Control
Laboratory Operations: Stability Studies, Holding Time Studies, Sample Management
Documentation: SOP Writing, COAs, Analytical Reports, Logbooks, Protocols
Software & Systems: LIMS, Empower, Microsoft Office
Audit Support: Regulatory Inspections, Internal Audits, Vendor Audits
Soft Skills: Root Cause Analysis, Cross-Functional Collaboration, Time Management, Attention to Detail
Empower – Waters
LabSolutions – Shimadzu
QNAP Storage