Senior QA Manager
Chennai · Senior
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Job description
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.
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Draft CT protocols and reports; support report writing and TV approval routing[
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Support cross-contamination assessments and quality-record documentation (NC/CC/CAPA as applicable).
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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.
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Familiarity with CMC documentation and electronic quality management systems.
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Ability to work across multiple product teams simultaneously and manage competing deadlines.
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Strong foundational understanding of drug development, pharmaceutical manufacturing processes, and trace-level impurity evaluations (specifically nitrosamines/NDSRIs)
Other Requirements
N/A
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