• 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: