Senior QA Manager

About the role

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

What you'll do

• 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

What you need

• Technical writing
• GMP
• Regulatory affairs
• Chemistry
• Any graduate