Dear All,

Greetings from Aizant Drug Research Solutions!!!

We have a requirement for Quality Control(Nitrosamines) team at our Manufacturing unit located at Hyderabad(Dulapally).

Experience: 5-8 Years

Job Purpose:
We are seeking a highly skilled Senior Analyst specializing in Nitrosamines and Nitrosamine Drug SubstanceRelated Impurities (NDSRIs). The selected candidate will lead the development, validation, and implementation of advanced analytical methods (LCMS/MS, GCMS/MS) for nitrosamine detection and support comprehensive risk assessments in line with EMA, USFDA, Health Canada, and ROW requirements. This role is critical to ensuring product safety, regulatory compliance, and successful lifecycle management of drug products.

Key Responsibilities:

- Lead method development and validation for tracelevel detection of nitrosamines/NDSRIs in APIs and finished dosage forms using LCMS/MS and GCMS/MS.
- Draft, review, and finalize method validation protocols, reports,



and regulatory documentation related to nitrosamine investigations.
- Interpret analytical data in compliance with GMP, ICH guidelines, and global regulatory expectations.
- Conduct and drive nitrosamine risk assessments for APIs, excipients, and drug products in collaboration with crossfunctional teams.
- Monitor and implement evolving international regulatory guidance on nitrosamine impurities.
- Provide technical support during audits, inspections, and client reviews.
- Mentor junior analysts and contribute to continuous improvement initiatives in laboratory practices.

Education:

Masters degree in Analytical Chemistry, Pharmaceutical Sciences, or related discipline

Note: Interested candidates can share the profile to [email protected]

📌 Senior Executive-Quality Control(Nitrosamines) (Hyderabad)
🏢 Aizant
📍 Hyderabad