Executive QC - Analytical Method Development

1. To prepare specification / Method of analysis for input material, in-process material, semi-finish product, finish product and stability testing.
2. To monitor compliance with USP revisions.
3. To Prepare Method Verification Protocol / Report and Method validation protocol / Report.
4. To prepare Stability protocols.
5. To Initiate and evaluate change control for the alternate source, USP monograph changes and Method optimization.
6. 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: