职位介绍
Job Summary
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
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 document 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
- 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)
Other Requirements
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福利待遇
•Learning Budget
必备技能
Quality assurance
Testing
Process control
关于HCL Technologies
Chennai
总部位置