Executive Analytical Method Development OSD GC-MS EandL

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

QUALIFICATIONS

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

Experience:

• 5 years or more in 5 - 8 Years
  
  

Specialized Knowledge: Licenses:

About Us

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.

About The Team

The Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.

Key Roles That The Human Resources Team Performs

Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.

Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.

Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.

Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance.

Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.

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