Your Name
QC Analyst · HPLC, GC, Dissolution, Method Validation, GMP
your.email@example.com | +91 XXXXX XXXXX | Vadodara, India | linkedin.com/in/your-profile
Summary
QC analyst with 3 years in GMP oral-solid-dosage plants, running HPLC, GC and dissolution testing for finished products and stability studies. Has tested 1,200+ samples and validated 5 analytical methods, with hands-on deviation, OOS and CAPA work at a US FDA-inspected site.
Experience
- Tested 1,200+ finished-product and stability samples by HPLC, GC and dissolution under cGMP, keeping right-first-time results at 98% across 2 audit cycles.
- Validated 5 HPLC assay and related-substances methods per ICH Q2, covering specificity, linearity, accuracy and robustness, with all 5 reports approved without rework.
- Led root-cause investigations for 14 OOS results and deviations using 5-Why and fishbone analysis, closing CAPAs on time and cutting repeat deviations 40% in a year.
- Maintained ALCOA+ data integrity in Empower 3 and LIMS for 3 HPLC systems, with zero data-integrity observations during a US FDA inspection.
- Executed dissolution testing for 300+ tablet and capsule batches on USP Apparatus 1 (basket) and 2 (paddle), meeting the 48-hour release timeline for 95% of batches.
- Wrote 6 analytical SOPs for UV, KF titration and dissolution, reducing training time for new analysts from 3 weeks to 10 days.
- Supported 3 stability studies under ICH Q1A by pulling and testing 180 samples on schedule across long-term and accelerated conditions.
Projects
- Developed an RP-HPLC method separating metformin and sitagliptin in under 8 minutes, with resolution above 4 and tailing factor below 1.5.
- Validated the method per ICH Q2 for linearity, precision and accuracy, achieving r² of 0.9998 and recoveries of 98.6–101.2% across 3 levels.
Skills
Analytical Techniques: HPLC, GC, Dissolution, UV Spectroscopy, KF Titration, Method Validation
Quality Systems: GMP, GLP, SOPs, Deviations, CAPA, OOS Investigation, Change Control
Data Integrity & Software: Data Integrity, ALCOA+, Empower 3, LIMS, 21 CFR Part 11
Stability & Compliance: Stability Studies, ICH Q1A, ICH Q2, Audit Readiness