LCMS Specialist - E&L Lab

4 - 9 years

4 - 9 Lacs

Posted:8 hours ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

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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Aurobindo Pharma logo
Aurobindo Pharma

Pharmaceuticals

Hyderabad

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