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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