1. Person should be M.Sc. with analytical chemistry or General chemistry with minimum 7-10 years experience.

2. Should be well versed with Gas chromatography / HSGC method development as per QbD, and analytical method validations as per ICH guide lines.

3. Should have exposure / handled documentation requirements for USFDA/EU/TGA/ICH guidance for Residual solvents and Genotoxic impurities method development & GTI validations by GC/HSGC.

4. Exposure in handling of regulatory / DMF deficiencies / customer queries.

5. Well versed in GLP and data review / lab deviations and OOS handling, CAPA etc.

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