16 Aug
|
HCLTech
|
Chennai
Chennai, Tamil Nadu
Job Summary
Senior scientific expert to provide cross-product scientific leadership within a nitrosamine risk-assessment programme. This role strengthens technical depth and consistency across the portfolio and partners closely with analytical development and confirmatory-testing function
Key Responsibilities
Provide cross-product scientific leadership on nitrosamine/NDSRI risk (formation mechanisms, root-cause, exposure assessment).Guide analytical method development (amine, nitrite methods) and predictive stability, with AD and VCL.Expert review of NRERs and control strategies; shape investigation/mitigation design.Proven experience independently resolving complex nitrosamine or related impurity-science issues.Ability to challenge and guide product teams, analytical development, sites,
and external laboratories.Act as a senior technical point of reference for the wider programme team.
Skill Requirements
PhD-level (or equivalent) expertise in analytical or synthetic chemistry.Demonstrated knowledge of nitrosamine / NDSRI science and regulatory expectations (FDA, EMA, Health Canada).Solid method-development and regulatory-science fluency.Experience providing technical leadership across multiple products or projects.
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📌 Senior QA Lead (Chennai)
🏢 HCLTech
📍 Chennai