Method Validation Analyst in Fresenius Kabi, India

Worked as Validation analyst and performed analytical method development of anticancer drugs for regulatory bodies like USFDA, Japan, Mexico.

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1. Successfully completed 3 methods transfer of Decitabine- a potent anti cancer drug (Assay, RS and

DMSO content with HPLC) with Fresenius Kabi Research Lab of Gurgaon.

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2. Faced audit of ISO:9001 and 14001, Auspira (Australia), Pfizer and Mexican Regulatory authority,

Denmark regulatory authority, WHO-GMP.

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3. Successfully completed 2 method transfers of Temsirolimus- a potent anti cancer drug (RS by GC and Acetic Acid content by IC) with Fresenius Kabi Research Lab of Gurgaon.

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4. Validation of IRINOTECAN HCl for JAPAN submission.