Research Associate : IRF Analytical

Lupin; Pune District; On-site; INR 600,000 - 900,000; Full time

Job summary

Lupin is seeking a scientist in Pune for analytical method development and regulatory-aligned data management. The role involves developing robust methods for assays, dissolution and related tests using HPLC, GC, UV and KF, while ensuring data integrity through BIOVIA records and GLP/GDP compliance.

You will perform routine analysis on market samples, prepare development reports and COAs, and contribute to method validation efforts within a GMP framework.

Qualifications

• Develop analytical methods for assays, dissolution, degradation products, residual solvents, and water content using HPLC/GC/UV/KF.
• Document data in BIOVIA ensuring integrity, traceability, audit trail, and electronic records compliance.

Responsibilities

• Perform routine/initial analysis of drug products for market samples/queries.
• Prepare method development protocols, reports, method equivalency reports and COA.
• Maintain lab safety, GLP, GDP compliance in the laboratory.

Skills

Analytical method development

GLP compliance

Data integrity

Education

Masters in Pharmacy or Analytical Chemistry

Tools

HPLC

GC

UV

KF

Job description

• To perform analytical method development of drug products for different tests like Assay/Dissolution/Degradation products/Residual solvents/water content by using advanced techniques like HPLC/GC/UV/KF
• To perform documentation through the BIOVIA system to ensure data integrity, traceability, version control, audit trail compliance, and secure electronic record management in accordance with applicable quality and regulatory requirements.
• Performing routine/initial analysis of drug products for market samples/query response.
• Preparation of method development protocols, reports, method equivalency report and COA
• To perform multimedia dissolution study and compatibility study and prepare report of the same.
• Maintaining lab safety compliance during analysis
• Maintaining GLP compliance in the laboratory.
• Maintaining GDP in the laboratory.

Work Experience

0-5 years

Education

Masters in Pharmacy or Analytical Chemistry