Job Description

Extractables & Leachables (E&L)

• Execute extractables and leachables studies for pharmaceutical packaging materials, process contact materials, and device components.
• Perform sample preparation, extraction studies, and analytical testing as per study protocols.
• Support identification and characterization of unknown compounds using mass spectrometry techniques.
• Interpret analytical data and generate scientifically sound conclusions.
• Assist in toxicological risk assessment by providing analytical data and impurity profiles.
• Prepare technical reports, study protocols, and regulatory documentation related to E&L activities.
• Support investigations related to packaging-related impurities and product quality concerns.

Analytical Development

• Develop, optimize, and troubleshoot analytical methods for identification and quantification of organic and inorganic impurities.
• Participate in method qualification, validation, transfer, and verification activities in accordance with ICH and regulatory guidelines.
• Perform root cause investigations and laboratory troubleshooting activities.
• Review raw data, chromatograms, spectra, and laboratory records for compliance and accuracy.

Instrumentation

Hands-on experience and working knowledge of:

• LC-MS/MS
• GC-MS
• HPLC/UHPLC
• GC-FID
• FTIR Spectroscopy
• pH Meter and other general laboratory instruments

Compliance & Documentation

• Maintain data integrity and GMP compliance in laboratory operations.
• Prepare and review SOPs, analytical procedures, protocols, and reports.
• Ensure adherence to laboratory safety and quality requirements.
• Support regulatory inspections, audits, and client interactions as required.

Education:

• B. Pharm B. Pharm - Required

• Master Degree (MS/MA) M. Sc. - Preferred

Experience:

• 5 years or more in 5 - 8 Years

Specialized Knowledge: Licenses: Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.