Senior QA Manager

Job description

Chennai, Tamil Nadu Job Summary 1. Technical / Documentation Support Specialist Experienced technical writer to support a large pharmaceutical nitrosamine risk-assessment programme. Support role, enabling scientific subject-matter experts to focus on technical decisions while this role manages the technical writing & documentation workload across a portfolio of ~20 product families Key Responsibilities Author and revise the core documentation set: Internal (INH) NRER, Regulatory NRER, and Risk Summary Reports, including revisions after Confirmatory Testing outcomes. • Draft CT protocols and reports; support report writing and TV approval routing[ • Support cross-contamination assessments and quality-record documentation (NC/CC/CAPA as applicable). • Work closely with cross-functional teams—including Analytical Development, Toxicology, Process Chemistry, MSAT, Quality Assurance, and Regulatory Affairs—to draft, review, and manage scientific justification reports Skill Requirements Proven scientific / technical writing experience in a GMP pharmaceutical environment. • Familiarity with CMC documentation and electronic quality management systems. • Ability to work across multiple product teams simultaneously and manage competing deadlines. • Strong foundational understanding of drug development, pharmaceutical manufacturing processes, and trace-level impurity evaluations (specifically nitrosamines/NDSRIs) Other Requirements N/A #body.unify div.unify-button-container .unify-apply-now: focus, #body.unify div.unify-button-container .unify-apply-#body.unify div.unify-button-container .unify-apply-now: focus, #body.unify div.unify-button-container .unify-apply-