Harshith

Analytical Chemistry professional with 10+ years of experience in Analytical Research & Development (AR&D) and Quality Control (QC), operations within the pharmaceutical API industry. Experienced in analytical method development, method validation, routine analysis, and regulatory compliance as per USFDA, EU-GMP, WHO, ICH, cGMP, and GLP guidelines. Skilled in handling sophisticated analytical instruments including HPLC, GC, UPLC, FTIR, UV, and KF Titrator.

Strong expertise in documentation, data integrity, laboratory management, and audit compliance.

Sr. Research Associate-I (AR&D) at Sthree Chemicals Pvt Ltd (2024-04 – 2026-04)

• Conducted instrumental analysis for R&D and API samples using HPLC and GC.
• Developed analytical methods and ensured compliance with cGMP and GLP standards.
• Prepared specifications, SOPs, and supported method validation activities.
• Coordinated laboratory activities and trained junior analysts.

Sr. Research Associate (AR&D) at Jubilant Pharmova Ltd. (2021-04 – 2024-03)

• Performed analysis of R&D, pilot, and finished product samples as per IP, USP, and EP standards.
• Operated and maintained analytical instruments including HPLC, UPLC, GC, FTIR, UV, and KF Titrator.
• Prepared Certificates of Analysis (COA) and supported regulatory audits.
• Ensured compliance with GMP documentation and laboratory practices.

Officer (AR&D) at Resonance Laboratories Pvt Ltd. (2019-07 – 2021-04)

• Conducted QC and R&D analysis as per pharmacopeial standards.
• Maintained calibration records and laboratory documentation.
• Ensured compliance with GMP requirements and analytical procedures.

Trainee Officer (QC) at Resonance Laboratories Pvt Ltd. (2015-08 – 2016-07)

• Assisted in sampling, calibration, and documentation activities in Quality Control department.
• Supported routine laboratory operations and GMP documentation practices.

Analyst at Soil Health Centre. (2017-01 – 2019-05)

• Analyzed soil samples and calibrated field instruments.
• Assisted in field sample collection and laboratory documentation activities.

M.Sc in CHEMISTRY – MANGALORE UNIVERSITY, ALVAS COLLEGE MOODBIDRI (2013 – 2015)

B.Sc in CBZ – SRI BHUVANENDRA COLLEGE KARKALA (2010 – 2013)