Quality Assurance Manager
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Quality Assurance professional with 15 years of experience in various roles within a variety of formulations – Semisolid, MDI, Topical Foam, Liquid, Nasal Spray & Solid dosage forms. Faced multiple times regulatory audit (USFDA, MHRA, ANVISA, EU, ISO 13485:2016 and WHO-GMP etc.).
Worked in green field project of Semi-solid dosage forms (Ointment, Cream and lotions) at Dr. Reddys from Jun-2014 to March 2018.
Exposure of IPQA, New product/Technology transfer activity, Document Control, Training Management (Aspire LMS), Batch release, APQR, Process Validation , QMS (Change control , deviation , incident ,OOS, Market complaints) , Self-inspection, Handling of Internal/ External/Regulatory audits, Regulatory submission, Vendor Management, SAP projects & Management Review.
Awarded with a certificate “Most Vigilant Employee of the Year” and Best initiative of the Year 2020 from President Global Quality Head -Glenmark pharmaceutical limited.
Got Chairman's Excellence Awards in Year 2022 for “Best Project Team” for Filing, Approval & Commercialization of NDA product
Bachelor of pharmacy (B.Pharmacy)
with 1st grade in year 2007