Vimlesh Kumar Email & Phone Number

I have anout 12 years of experience in Regulated quality assurance department. I have worked in Pharmaceutical and Bio-pharmaceutical industries. Started carrier in May-2012 from Bharat Serums and vaccines limited and was associated with them till 8th Feb-2014. I have worked in Wockhardt limited Biotech division Aurangabad, Cipla Biotec, Goa. Zydus Cadilla, Goa, Lupin Biotech, Pune and currently working with Alvotech, Iceland since Dec- 2021Hands on experience:*Handling of QAMS elements like, Deviation, change Control, Market complaint, CAPA, OOS, OOT, Quality Risk Assessment.* Handling IPQA activities in mammalian and microbial drug substance manufacturing activity. Handled Multiple Biotechnology product, Etanercept, Filgrastim, Peg- Filgrastim, Ranibizumab, Aflibercept, Trastuzumab, Insulin, Glargine, Aspart.Handling of IPQA team as team leader. Preparation and Review of technical document, TTD, Product Characterization report, MFR, Master BPR.Preparation and Review of PV, CV, Hold time study, Transportation study protocol and reports.Handling and management of Cell Bank.Self inspection, planning, coordination and compliance verification.Preparation and review of APQR.Training and developmentVendor Qualification.* I have handle IPQA in finished product packaging line, dispatch activity, review of BPR, dispatch documents etc.* Qualifications and Validation of Aseptic area, equipment like Tunnel, Autoclave, DHS, Biosafety cabinet, vial and ampule washing machine, Dynamic pass box, Filling machine etc.* Achievements: I have been awarded with best performer award in Wockhardt.

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  School Of Pharmaceutical Sciences, Shiksha 'O' Anusandhan University, Bhubaneshwar

  Pharmacy