Research Associate : IRF Analytical

Lupin Limited; Pune District; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Lupin Limited in India is seeking a skilled professional to perform analytical method development for drug products, using HPLC, GC, UV and KF techniques. The role includes documentation in BIOVIA, data integrity and audit trails to meet regulatory requirements.

The candidate will perform routine analyses, prepare development protocols and COAs, and contribute to dissolution and compatibility studies while upholding GLP, GDP and lab safety standards.

Qualifications

• Masters in Pharmacy or Analytical Chemistry.

Responsibilities

• Perform analytical method development for tests like Assay, Dissolution, Degradation products, Residual solvents, water content using HPLC/GC/UV/KF.
• Document data in BIOVIA system ensuring data integrity, traceability and audit trails in compliance with quality and regulatory requirements.
• Carry out routine analysis of drug products for market samples or queries.
• Prepare method development protocols, reports, method equivalency reports and COAs.
• Contribute to multimedia dissolution and compatibility studies and report generation.
• Maintain lab safety compliance during analysis.
• Maintain GLP and GDP in the laboratory.

Skills

Analytical method development

Documentation & compliance

GLP & GDP awareness

Lab safety practice

Data integrity

Education

Masters in Pharmacy or Analytical Chemistry

Tools

HPLC

GC

UV

KF

BIOVIA system

Job description

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
## Competencies