Leachables & Extractables (L&E) Analyst

As a Leachables & Extractables (L&E) Analyst at Anazeal Analytical & Research Pvt. Ltd., located in Navi Mumbai, Maharashtra, you will be responsible for performing analytical testing and characterization of extractables and leachables in pharmaceutical containers, closures, and medical devices. Your role will involve method development, validation, and data interpretation in compliance with regulatory guidelines such as USP, ISO, and ICH. Key Responsibilities: - Perform Extractables and Leachables studies for pharmaceutical packaging materials, process equipment, and medical devices. - Conduct sample preparation, extraction, and analysis using analytical instruments such as GC-MS, LC-MS, ICP-MS, FTIR, UV-Vis, etc. - Develop and validate analytical methods following ICH and USP guidelines. - Interpret analytical data and prepare technical reports identifying and quantifying leachables and extractables. - Ensure all activities comply with GMP/GLP and internal quality systems. - Support risk assessment studies related to packaging and process materials. - Maintain and calibrate analytical instruments while ensuring documentation meets regulatory standards. - Collaborate with cross-functional teams (QA/QC, R&D, Regulatory Affairs) to meet project requirements. Required Qualifications & Skills: - Education: M.Sc. / M.Pharm in Analytical Chemistry, Pharmaceutical Chemistry, or related discipline. - Experience: Minimum 2 years hands-on experience in Leachables & Extractables or related analytical testing. - Proficiency in operating LC-MS/MS, GC-MS, ICP-MS, and HPLC systems. - Strong understanding of regulatory requirements (USP <1663>, <1664>, ICH Q3D, ISO 10993). - Excellent analytical and problem-solving skills. - Good documentation and report-writing abilities. - Familiarity with data integrity principles. Job Type: Full-time Benefits: - Provident Fund Work Location: In person,