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 a 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.
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 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)
Application Process/Equal Chance 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 reviewed, and shortlisted candida
📌 Senior Scientific Expert (Tamil Nadu)
🏢 NovintiX
📍 Tamil Nadu