Description

1. Perform and review method validation of Assay, Dissolution, Related compound and Residual solvents etc. for current projects using instruments like HPLC,UV, IC ,GC,ICP MS and AAS etc.

2. Preparation of method validation/verification protocol (API and finish product) like HPLC, GC, IC, and AAS etc.
- Preparation of STPs and Specifications as per method validation protocol.
- Check the method transfer protocol/report and methods and resolve the query of Assay, Dissolution, Related compound, Elemental analysis and Residual solvents etc.
- To attain and complete self-training record.

6.To coordinate with ARD-Development, QA and QC.

- Ensure timely completion of validation/verification and method transfer.

Additional Responsibilities:

- Activities other than the defined in the Job Responsibility are to be done, as per the requirement of HOD

Qualifications

Education:

- Master Degree (MS/MA) M. Sc. - Required

- M. Pharm M. Pharm - Preferred

Experience:

- 5 years or more in 5 - 8 Years

Specialized Knowledge: Licenses:

📌 Senior Officer, Analytical R&D Injectable | Method Validation (Sanand)
🏢 Amneal
📍 Sanand