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)

Must Have Skill

Material Science

Positive to Have Skill

Other Requirements

N/A

📌 Senior QA Manager (India)
🏢 HCLTech
📍 India