LCMS Specialist - E&L Lab Aurobindo Pharma

4.0 - 9.0 years

4 - 9 Lacs

Hyderabad

Work from Office

Key Responsibilities: Conduct comprehensive Extractables and Leachables (E&L) analysis using Liquid Chromatography-Mass Spectrometry (LC-MS) for pharmaceutical packaging and drug delivery systems. Develop, optimize, and validate LC-MS methods for the detection and quantification of E&L compounds. Analyze, interpret, and report LC-MS data to assess potential risks associated with material impurities. Prepare and review Standard Operating Procedures (SOPs), study protocols, validation reports, and analytical reports for E&L studies. Ensure compliance with regulatory guidelines (USP, ICH, FDA, ISO) and Good Laboratory Practices (GLP). Maintain, troubleshoot, and calibrate LC-MS equipment, ensuring the instrumentation is always operating at peak performance. Collaborate with R&D, formulation, packaging, and quality assurance teams to ensure the safe use of materials in drug products. Stay updated on current industry standards and evolving regulatory requirements for extractables and leachables testing. Participate in internal and external audits, providing technical expertise on E&L testing as required. Effectively manage laboratory workflows to meet project timelines and ensure accurate, high-quality data generation.

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