Senior QA Lead
Chennai · Staff/Principal
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HIGH
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First 72 hours
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Job description
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).
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Guide analytical method development (amine, nitrite methods) and predictive stability, with AD and VCL.
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Expert review of NRERs and control strategies; shape investigation/mitigation design.
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Proven experience independently resolving complex nitrosamine or related impurity-science issues.
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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.
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Demonstrated knowledge of nitrosamine / NDSRI science and regulatory expectations (FDA, EMA, Health Canada).
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Strong method-development and regulatory-science fluency.
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Experience providing technical leadership across multiple products or projects.
Other Requirements
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