Amneal Hiring For Documentation AR&D

Company: Amneal Pharmaceuticals, Inc. (NYSE: AMRX)


Job Location: Ahmedabad, India

Qualification: M. Sc. / M. Pharm

Experience: 02-07 Years

Department: Documentation (Analytical R&D Injectable)

Key Responsibilities:

  • Preparation of SOPs, Specifications, and methods of analysis for raw materials, in-process, and finished products.
  • Review of DMF to prepare analytical methods and specifications.
  • Preparation of justification of specification and characterization reports.
  • Preparation of analytical reports including equivalency, investigation studies, reconstitution studies, dilution studies, elemental risk assessment reports, and nitrosamine impurity risk assessments.
  • Preparation of documents for Form 29 applications.
  • Good understanding of impurity profiling.
  • Compliance with current agency requirements.
  • Familiarity with ICH quality guidelines.
  • Knowledge of pharmacopoeias.
  • Strong communication skills, particularly in writing quality documents and coordinating with cross-functional teams.


How To Apply:

Interested candidates can share their CV on the following email addresses:

kavitriy@amneal.com or yash.ojha@amneal.coml




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