Nitrosamine / Genotoxic Impurities Analyst

Sipra Labs Ltd; Hyderabad; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Sipra Labs Ltd in Hyderabad, India seeks an experienced Analytical Chemist to perform trace-level nitrosamine analysis by LC-MS/MS and GC-MS/HRMS, aligned with ICH M7 guidance and current nitrosamine rules. The role emphasizes method development, validation at ultra-trace levels, and data integrity. The position involves QA/regulatory support, OOS/OOT investigations, audits, and daily instrument maintenance.

Qualifications

• Experience in trace-impurity / mass-spectrometry analysis.
• Understanding of ICH M7 guidelines for nitrosamines.
• Strong data integrity and record-keeping (ALCOA++).

Responsibilities

• Perform nitrosamine analysis (NDMA, NDEA, NMBA, NDIPA, NEIPA, NMPA, etc.) by LC-MS/MS and GC-MS/HRMS.
• Develop, optimise and validate ultra-trace methods with emphasis on sensitivity and recovery.
• Support QA/Regulatory activities and audits; manage data and instrument maintenance.

Skills

Trace-level analysis

Mass spectrometry

LC-MS/MS

GC-MS/HRMS

ALCOA++

Education

M.Sc in Chemistry/Analytical Chemistry

M.Pharma

Tools

LC-MS/MS

GC-MS/HRMS

Job description

Perform and develop trace-level analysis of nitrosamine and genotoxic/mutagenic impurities by LC-MS/MS and GC-MS/HRMS in line with ICH M7 and current nitrosamine guidance, ensuring sensitive, data-integral results supporting risk assessment and control.

Key responsibilities: perform trace-level nitrosamine analysis (NDMA, NDEA, NMBA, NDIPA, NEIPA, NMPA, etc.) by LC-MS/MS and GC-MS/HRMS; analyse genotoxic/mutagenic impurities per ICH M7 (assessment, control, AI/PDE/TTC); develop, optimise and validate ultra-trace methods (low ppb/ppm) including sensitivity, recovery and matrix effects; support nitrosamine risk assessments and root-cause with QA/Regulatory/Method Development; operate, tune and maintain LC-MS/MS and GC-MS/HRMS and verify system suitability; manage reference and isotope-labelled internal standards with safety controls; record raw data, chromatograms and calculations contemporaneously (ALCOA++); report and investigate OOS/OOT and perform confirmatory testing; maintain controlled handling/safety of mutagenic substances and waste; and support internal, NABL, FDA and client audits.

Grade LM-4 | Individual Contributor / Specialist | Division: Analytical (Analytical Chemistry – Genotoxic & Nitrosamine Impurities) | Education: M.Sc (Chemistry/Analytical Chemistry) or M.Pharma | Experience: 6–10 years in trace-impurity / mass-spectrometry analysis | Reports to: Group Leader – Analytical.