Leachables & Extractables (L&E) Analyst

Job Title:

Leachables & Extractables (L&E) Analyst / Extractable & Leachable Specialist

Company:

Anazeal Analytical & Research Pvt. Ltd.
Location: Navi Mumbai, Maharashtra

Experience Required:

Minimum 2 years in analytical research, with specific experience in Leachables and Extractables studies.

Job Summary:

The L&E Analyst will be responsible for performing analytical testing and characterization of extractables and leachables in pharmaceutical containers, closures, and medical devices. The role involves method development, validation, and data interpretation in compliance with regulatory guidelines (USP, ISO, ICH, etc.).

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 as per ICH and USP guidelines.
• Interpret analytical data and prepare technical reports with identification and quantification of 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 and ensure documentation as per regulatory standards.
• Collaborate with cross-functional teams (QA/QC, R&D, Regulatory Affairs) to support 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

Pay: ₹15,000.00 - ₹50,000.00 per month

Benefits:

• Provident Fund

Work Location: In person