QC Analyst
Analytical Chemistry

About the Role

As QC Analyst – Analytical Chemistry at our Hosur Campus, you will conduct routine and non-routine analytical testing of raw materials, APIs, intermediates, in-process samples, and finished pharmaceutical products. Your work directly supports the release of products to global markets including the UK (MHRA), Australia (TGA), and WHO-regulated territories.

You will work in a modern, fully-equipped QC laboratory with Agilent and Waters HPLC systems, Shimadzu GC instruments, and modern LIMS infrastructure — all within a culture of scientific rigour and data integrity.

Key Responsibilities

• Perform HPLC, GC, UV-Vis spectrophotometry, IR (ATR/FTIR), Karl Fischer titration, and wet chemistry analyses on APIs, intermediates, and finished products
• Execute in-process testing, batch release testing, and stability sample analysis per approved analytical methods and SOPs
• Carry out method verification and method validation studies per ICH Q2(R1) guidelines, including linearity, accuracy, precision, specificity, and robustness
• Prepare, review, and approve analytical test records, raw data logs, certificates of analysis (COAs), and calibration records — maintaining full data integrity per ALCOA+ principles
• Investigate Out-of-Specification (OOS) and Out-of-Trend (OOT) results, perform root cause analysis, and document findings in the deviation management system
• Maintain laboratory instruments — perform qualification checks, system suitability tests, and calibration scheduling per equipment SOPs
• Manage reference standards, working standards, and reagent inventories with proper documentation
• Support pharmacopoeia (IP/BP/USP/EP) compliance testing and pharmacopoeial method equivalency assessments
• Participate in MHRA, TGA, and internal GMP audits — respond to laboratory-related observations and implement CAPAs

Qualifications & Experience

• M.Sc. in Analytical Chemistry, Pharmaceutical Chemistry, or Chemistry; B.Sc. with strong practical experience will be considered
• 2–4 years of QC analytical laboratory experience in a pharmaceutical manufacturing environment (API or formulation)
• Hands-on proficiency with HPLC (Agilent 1260/1290 or Waters Alliance/Acquity) and GC (Shimadzu or Agilent); experience with method development preferred
• Solid understanding of cGMP requirements, 21 CFR Part 11 electronic records, and data integrity frameworks
• Familiarity with IP, BP, and/or USP pharmacopoeia testing procedures, specifications, and general chapters
• Experience with LIMS systems (LabWare, LabVantage, or equivalent) for test request management and result entry
• Ability to write clear, accurate, and compliant analytical test records and technical reports
• Strong attention to detail, systematic approach to problem-solving, and good laboratory practice (GLP) habits