Sr Research Associate Analytical RandD

Endo; Palakkad; On-site; INR 700,000 - 900,000; Full time

Job summary

Endo seeks a highly motivated analytical R&D chemist with 4 to 7 years’ experience to join our research and development team. The role focuses on developing and validating analytical methods for API testing in compliance with ICH and regulatory requirements.

You will support method development, validation, transfer, and regulatory documentation, working with HPLC, GC, LCMS, GCMS and ICPMS instruments in a GLP/gCGMP environment. On-site lab duties and data integrity are essential.

Qualifications

• 4 to 7 years’ experience in developing and validating analytical methods for testing of API
• Experience in GLP/gCGMP environment and wet analysis and instrumentation

Responsibilities

• Maintain housekeeping and adhere to GLP/cGMP norms in ARD Lab
• Support analytical method development for projects in a timely manner
• Support analytical validation/Method transfer for projects in a timely manner
• Provide regulatory support as per committed timeline
• Support production by analytical issues, yield improvement and process optimization
• Analyze RM, KSM, in-process, cleaning, intermediates, stability and API; report preparation
• Documentation of Reference standards as per MTH
• Support EI analysis by ICPMS/IC/GCMS/LCMS timely
• Ensure completion of documents & data integrity in regulatory environment
• Calibrate/maintain analytical instruments
• Review all executed analytical documents
• Maintenance of HPLC/GC Columns
• Partial validation, holding study, DMF queries and physico-chemical studies
• Responsibility for QMS: Change control, Deviation, CAPA and related QMS

Education

Postgraduate degree in Chemistry/Analytical

Tools

HPLC

GC

GCMS

IR

LCMS

ICPMS

Job description

Job Description

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 thorough 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.

Requirements: