Executive QC - Analytical Method Development

Amneal Pharmaceuticals • Full-time • Ahmedabad, IN • 1w ago

Job Description

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

QUALIFICATIONS

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

Experience

5 years or more in 5 - 8 Years

Specialized Knowledge: Licenses:

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