Sr Research Associate, Analytical R&D

Endo; Perambalur; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Endo in Tamil Nadu, India seeks a highly motivated analytical R&D chemist with 4–7 years of experience and a postgraduate degree in Chemistry/Analytical. The role involves developing and validating analytical methods for API testing and regulatory release, under ICH guidelines, with strong GMP/GLP practice and proficiency in HPLC/GC/GCMS/IR/LCMS.

The incumbent will ensure GLP/cGMP compliance in the ARD Lab, support method development and validation, assist with regulatory timelines, and provide

Qualifications

• 4 to 7 years’ experience and post graduate chemistry/Analytical.
• Developing and validating analytical methods for testing API and release per ICH/regulatory.
• GMP operation knowledge and wet analysis with analytical instruments.

Responsibilities

• Maintain GLP/cGMP in ARD Lab and keep instruments clean.
• Support analytical method development for projects on time.
• Assist analytical validation/method transfer for projects on time.
• Support regulatory requirements within committed timelines.
• Provide analytical support to production for issue resolution and yield improvement.
• Sample/analyze RM, KSM, in-process, intermediate, stability; report preparation.
• Analyze Reference standards and related documentation per MTH.
• Support EI analyses by ICPMS, IC, GCMS, LCMS timely.
• Ensure data integrity and regulatory-compliant documentation.
• Support calibration and preventive maintenance of all analytical instruments.
• Review executed analytical documents and maintain HPLC/GC columns.
• Perform partial validation, holding studies, DMF queries, and physiochemical studies.
• Handle QMS responsibilities like Change Control, Deviations, and CAPA.

Skills

Analytical Chemistry

GMP GLP knowledge

Documentation

Education

Postgraduate in Chemistry/Analytical

Tools

HPLC

GC

GCMS

IR

LCMS

Job description

Job Description Summary

We are seeking a highly motivated analytical R&D chemist to join our research and development team.
We require 4 to 7 years’ experience and post graduate chemistry/Analytical in developing and validating analytical methods for testing of API and release according to ICH and regulatory requirements.
Having through knowledge of GMP operation and ability to work on Wet analysis and analytical instruments HPLC/GC/GCMS/IR/LCMS.

Job Description

To ensure good housekeeping and adhere to GLP/cGMP norms in ARD Lab and maintain cleanliness of instruments and equipment’s.

To support and perform analytical method Development for each project timely.

To support and perform analytical validation/Method transfer for each project timely

To support regulatory requirement as per committed timeline.

To provide analytical support related to production for sorting out issues, yield improvement and further optimizing the process as per schedule.

To Sample/analyze RM,KSM, in process, cleaning, intermediate, stability and API and report preparation

To Analysis and documentation of Reference standard samples as per MTH

To support and perform analytical method development/Validation for EI by ICPMS and,IC,GCMS LCMS timely.

To ensure completion of documents & data integrity and regulatory environment

To support for Calibration/Preventive maintenance of all analytical instruments

Review of all executed analytical documents.

Maintenance for HPLC /GC Columns.

To perform Partial validation, Holding study, DMF queries and physiochemical studies

Responsibility for QMS system like Change control, Deviation and CAPA and related to QMS.