Sr Research Associate, Analytical R&D

Paladin Labs Inc.; India; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Paladin Labs Inc. seeks a Sr Research Associate in Analytical R&D in India (Alathur).

The role requires 4–7 years’ experience in developing and validating analytical methods for API testing under ICH/regulatory guidelines, with strong GMP/GLP/cGMP discipline and hands-on wet analysis using HPLC/GC/GCMS/IR/LCMS. You will support method development, validation/transfer, documentation, data integrity, and regulatory submissions while aiding production in yield improvement and process optimization,

Qualifications

• 4 to 7 years’ experience in analytical R&D with post graduate qualification.
• Develop and validate analytical methods for API testing per ICH/regulatory requirements.
• Strong knowledge of GMP operations, GLP/cGMP norms, instrument maintenance and data integrity.

Responsibilities

• Support and perform analytical method development for each project.
• Assist in analytical validation/transfer and regulatory documentation timelines.
• Provide analytical support to production for yield improvement and process optimization.
• Sample and analyze RM, in-process, intermediates, stability, and API samples; report preparation.
• Review executed analytical documents and maintain instrument calibration/maintenance.
• Contribute to QMS processes including change control, deviations, and CAPA.

Skills

Analytical method development

Analytical method validation

Regulatory compliance

Documentation & data integrity

Education

Postgraduate chemistry/Analytical

Tools

HPLC

GC

GC-MS

IR

LC-MS

ICP-MS

Job description

## Sr Research Associate, Analytical R&DApply: India - Alathur: Full time: Posted Yesterday: R003060**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 timelyTo 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 preparationTo Analysis and documentation of Reference standard samples as per MTHTo 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 environmentTo support for Calibration/Preventive maintenance of all analytical instrumentsReview of all executed analytical documents.Maintenance for HPLC /GC Columns.To perform Partial validation, Holding study, DMF queries and physiochemical studiesResponsibility for QMS system like Change control, Deviation and CAPA and related to QMS.