Executive, Analytical R&D Documentation Injectable at Amneal Pharmaceuticals, Ahmedabad
A rare chance has emerged for experienced professionals in the pharmaceutical sector. This Analytical R&D Documentation opportunity at Amneal Pharmaceuticals in Ahmedabad offers the chance to contribute to drug substance and drug product development. Candidates with 5-8 years of relevant experience are encouraged to apply.
About the Company
Amneal Pharmaceuticals is a global pharmaceutical company that focuses on developing, manufacturing, and distributing generic and specialty medications. The company is committed to providing high-quality, affordable medicines to improve patient outcomes. With a strong emphasis on innovation and quality, Amneal operates in various therapeutic areas and is dedicated to maintaining the highest standards in pharmaceutical manufacturing.
Job Details:
- Position: Executive, Analytical R&D Documentation
- Location: Ahmedabad
- Experience Required: 5-8 years
Analytical R&D Documentation Job Description
The Analytical R&D Documentation role is responsible for managing and executing analytical R&D documentation activities to ensure accuracy, consistency, and compliance with regulatory and data integrity requirements across drug substance and drug product development. The role supports preparation, review, and lifecycle management of analytical documents including protocols, reports, specifications, and validation records. The incumbent ensures adherence to data integrity principles (ALCOA+), GLP/GMP standards, and regulatory guidelines. It drives documentation workflows, supports change control processes, and ensures timely availability of compliant documentation for development, validation, and regulatory submissions. The role collaborates with cross-functional teams to standardize documentation practices, maintain audit readiness, and enable reliable data reporting to support scientific and regulatory decision-making.
Key Responsibilities
- Preparation of SOPs, Specifications, and method of analysis (Raw material, In-Process and Finished product).
- Review of DMF to prepare Analytical method and specification.
- Preparation of justification of specification and characterization report.
- Preparation of analytical reports (like Equivalency, Investigation study, Reconstitution study or dilution study, Elemental Risk Assessment Report, Nitrosamine Impurity Risk assessment).
- Preparation of Documents for form 29 Applications.
- Good understanding for Impurity profiling.
- Well versed with current agency requirements.
- Well versed with ICH quality guidelines.
- Good knowledge for Pharmacopoeia.
- Good communication, especially writing skills for preparing quality documents and coordination with Cross functional team.
How to Apply
Interested candidates can apply through the following link:
Conclusion
This is an excellent Analytical R&D Documentation opportunity for qualified candidates to join Amneal Pharmaceuticals. Interested individuals are encouraged to apply at the earliest to be considered for this pivotal role in drug development.
