Trainee Executive: IRF Analytical

Lupin; Pune District; Vor Ort; INR 350.000 - 550.000; Vollzeit

Zusammenfassung

Lupin is seeking a analytical chemist for analytical method development of drug products using HPLC/GC/UV/KF. The role involves documentation in BIOVIA to ensure data integrity, traceability and audit trails in line with quality and regulatory requirements.

You will perform routine/initial analysis of market samples, prepare development protocols and COA, and contribute to dissolution, compatibility studies, and maintaining GLP/GDP in the laboratory.

Qualifikationen

• Develop analytical methods for drug products (Assay, Dissolution, Degradation products, Residual solvents, water content) using HPLC/GC/UV/KF.
• Document data in BIOVIA with traceability, version control, audit trails and regulatory compliance.
• Perform routine/initial analysis of market samples and queries.
• Prepare method development protocols, reports, method equivalency reports and COA.
• Conduct multimedia dissolution and compatibility studies and report findings.
• Maintain lab safety, GLP, and GDP compliance.

Aufgaben

• Perform analytical method development of drug products for tests such as Assay/Dissolution/Degradation products/Residual solvents/water content using HPLC/GC/UV/KF.
• Document data in BIOVIA ensuring data integrity, traceability, version control, and audit trails.
• Carry out routine/initial analysis of market samples and respond to queries.
• Prepare method development protocols, reports, method equivalency reports and COA.
• Conduct multimedia dissolution and compatibility studies and compile reports.
• Maintain GLP and GDP compliance and lab safety.

Kenntnisse

Analytical method development

Documentation

Data integrity & compliance

Lab safety

Ausbildung

Masters in Pharmacy or Analytical Chemistry

Tools

HPLC

GC

UV

KF

Jobbeschreibung

• 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