Nitrosamine - Senior Analyst

Dear All,

We are looking for Nitrosamine exposure candidates who are having an experience of 3-5 Years into the industry.

Responsibilities:

• Lead method development and validation for trace-level detection of nitrosamines and NDSRIs using advanced instrumentation (GC-MS/MS, LC-MS/MS).
• Perform root cause analysis and establish robust impurity control strategies based on analytical data and scientific rationale.
• Prepare and review method validation protocols, risk assessment reports, and regulatory documentation for nitrosamine-related investigations.
• Interpret analytical data in compliance with GLP, ICH guidelines, and regulatory agency expectations.
• Drive nitrosamine risk assessments for APIs, excipients and finished dosage forms in collaboration with cross-functional teams.
• Stay up to date with evolving international regulations and scientific guidance on nitrosamine impurities.
• Provide technical support during regulatory inspections, audits, and client reviews.
• Mentor junior analysts and contribute to continuous improvement initiatives in laboratory practices.

Note: Interested candidates can share their updated resume to sonyjeevitha.degala@aizant.com