Sr Research Associate, Analytical R&D

Par Health, Inc.; Palakkad; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Par Health, Inc. seeks a highly motivated analytical R&D chemist to join our research and development team. With 4–7 years’ experience in developing and validating analytical methods for API testing, you will ensure compliance with ICH, GMP and regulatory requirements.

The role covers GLP/cGMP adherence, wet analysis, and instrument work (HPLC, GC, GC-MS, LC-MS, IR). You will support method development, validation/transfer, regulatory filings, and production support to improve yield and optimize

Qualifications

• Post graduate chemistry/analytical in developing and validating analytical methods.
• Experience testing API and release according to ICH and regulatory requirements.
• Strong knowledge of GLP/cGMP norms in ARD Lab and instrument maintenance.

Responsibilities

• Ensure good housekeeping and adhere to GLP/cGMP norms in ARD Lab.
• Support analytical method development for projects in a timely manner.
• Perform analytical validation and method transfer for projects.
• Support regulatory requirements within committed timelines.
• Provide analytical support to production for yield improvement and process optimization.
• Sample and analyze RM, KSM, in-process, cleaning, intermediates, stability, and API.
• Analyze and document reference standards as per MTH.
• Support analytical development/validation for EI by ICPMS and IC/GCMS/LCMS timely.
• Ensure data integrity and regulatory documentation; support calibration/maintenance of instruments.
• Review all executed analytical documents and maintain HPLC/GC columns.
• Carry out partial validation, holding studies, DMF queries and physiochemical studies.
• Support QMS processes like Change Control, Deviation, and CAPA.

Skills

Analytical method development

Analytical method validation

Regulatory compliance (ICH, GMP)

Wet chemistry

Education

Postgraduate degree in Chemistry/Analytical Chemistry

Tools

HPLC

GC

GC-MS

LC-MS

IR

ICP-MS

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.