Senior Executive-Quality Control(Nitrosamines)

Aizant Drug Research Solutions Pvt. Ltd.; Hyderabad; On-site; INR 1,200,000 - 2,200,000; Full time

Job summary

Aizant Drug Research Solutions Pvt. Ltd. in Hyderabad seeks a Senior Analyst with expertise in nitrosamines to lead the development and validation of LCMS/MS and GCMS/MS methods for nitrosamines and NDSRIs in APIs and finished dosage forms.

You will draft regulatory documentation, perform risk assessments, and ensure compliance with GMP/ICH and global guidance. Mentoring junior staff and supporting audits are key parts of the role.

Qualifications

• 5–8 years of experience in nitrosamines analysis.
• Master's degree in Analytical Chemistry or Pharmaceutical Sciences.
• Experience with method development and validation for trace nitrosamines.

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.

Skills

LCMS/MS

GCMS/MS

Nitrosamines

NDSRIs

Regulatory compliance

GMP/ICH

Risk assessment

Mentoring

Education

Master's in Analytical Chemistry

Tools

LCMS/MS

GCMS/MS

Job description

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 [e-mail]