- To prepare specification / Method of analysis for input material, in-process material, semi-finish product, finish product and stability testing.

- To monitor compliance with USP revisions.

- To Prepare Method Verification Protocol / Report and Method validation protocol / Report.

- To prepare Stability protocols.

- To Initiate and evaluate change control for the alternate source, USP monograph changes and Method optimization.

- To prepare regulatory Filing Documents for ANDA/ Site Transfer:

• Batch Analysis – 32S/32P

• Reference Standards – 32S/32P

• Characterization of Impurities – 32S/32P

• Justification of Specification – 32S/32P

• Facility Templates

• Stability Reports

• 5313 Reports (Dissolution Comparative test)

• QOS & Stability Overview - 32S/32P (If ANDA)

Education:

- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred

Experience:

- 5 years or more in 5 - 8 Years

Specialized Knowledge: Licenses:

📌 Executive QC - Analytical Method Development (Ahmedabad)
🏢 Amneal Pharmaceuticals
📍 Ahmedabad