Venkatesh Naidu
QC Chemist (HPLC)
venkatesh.naidu@example.com · +91 91XXX XXX74 · Visakhapatnam, Andhra Pradesh · linkedin.com/in/venkatesh-naidu-example
Summary
Quality control chemist with 5 years of experience in USFDA- and EU-GMP-approved API and oral solid dosage plants. Hands-on with HPLC, GC, dissolution, Karl Fischer and UV under cGMP and ALCOA+ data-integrity practices, and experienced in OOS/OOT investigations and regulatory audits.
Skills
- HPLC (Empower 3)
- Gas chromatography
- Dissolution testing
- Karl Fischer titration
- UV-Vis spectroscopy
- OOS / OOT investigation
- Instrument calibration
- cGMP and GLP documentation
Core skills
Data integrity (ALCOA+) · Audit readiness · Root cause analysis · Analytical accuracy · Teamwork with QA and production
Work experience
Executive, Quality Control, Godavari Lifesciences Ltd, Visakhapatnam
May 2023 – Present
- Perform assay, related substances and residual solvent testing on HPLC and GC using Empower 3 for 25–30 finished API batches a month.
- Investigated 6 OOS and 4 OOT results with QA, identifying root causes and closing CAPAs within agreed timelines.
- Faced USFDA and EU-GMP inspections as a QC analyst; the lab received no data-integrity observations.
- Cut HPLC run time for one impurity method by 35% after a validated method change, freeing about 40 instrument hours a month.
QC Chemist, Srikakulam Pharma Formulations Pvt Ltd, Srikakulam
Jul 2021 – Apr 2023
- Tested raw materials, in-process and finished tablets for dissolution, assay, KF water content and uniformity of dosage units.
- Calibrated HPLC, dissolution apparatus, UV and KF titrators as per schedule and kept logbooks inspection-ready.
- Prepared and standardised volumetric solutions and maintained working standards and reagent inventory.
Education
M.Sc, Analytical Chemistry
2019 – 2021
Andhra University affiliated college, Visakhapatnam · 78%
B.Sc, Mathematics, Physics and Chemistry
2016 – 2019
Government Degree College, Vizianagaram · 81%
Certifications
- Training on data integrity and ALCOA+ principles, Company GMP training programme, Feb 2024
Languages
English (Professional) · Telugu (Native) · Hindi (Conversational)