About the Company:

NovintiX is a global engineering and digital transformation company with operations across multiple countries that helps leading organizations build innovative products and solve complex business challenges. We work across industries such as Medical Devices, Life Sciences, Healthcare and Manufacturing, delivering engineering, digital, and consulting solutions.

Position Summary

We are seeking an 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

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

Skills & Experience:
- Proven scientific / technical writing experience in a GMP pharmaceutical setting.
- 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)

Application Process/Equal Opportunity Statement:

To apply for this position, please submit your application through job portals or by email to [email protected]. Applications received through these channels will be review

📌 Technical / Documentation Support Specialist (Tamil Nadu)
🏢 NovintiX
📍 Tamil Nadu