Executive QC - Analytical Method Development

Amneal Pharmaceuticals · Ahmedabad

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  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)

Responsible for analytical method development, verification, and validation; preparation of specifications, stability protocols, and reports; monitoring USP updates; evaluation of change controls; and preparation of regulatory filing documents for ANDA and site transfer.

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