Akhil Krishnan

Experience

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  Mylan

  May 2016 - Dec 2017

  Corporate Validation Group

  Preparation of IQ , OQ, PQ protocols and execute them for various equipment's at injectables plant. Knowledge in filtration technique. Media fill.

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  SUN PHARMA

  Dec 2017 - Sept 2019

  Technology Transfer

  Execution of various complex injectables trail and scale up process on large scale equipment. And also preparing the report for scale up batch, containment approach for new product, and also involving in Exhibit batch, PV batch. Knowledge in wet milling, inline homogenization, Refiner scalpers and vanrax PFS technology. Skilled in sterile suspension, emulsion and solution technology.

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  Meiji seika pharma

  Aug 2019 - Oct 2022

  Assistant Manager

   Initiation of product information form of site transfer validation, R&D project and customer project. Complying of Dossier (Module 3) and Sending unit documents for Tech Pack Review of Process Validation protocol as per Dossier and Process validation report. Review Hold Time study Protocol and Hold time study ReportReview of Raw Materials Specifications as per Product requirementPreparation of Gap Analysis and Gap Summary with respect to product as per Dossier(Module 3)and sending unit documents Initiation of planning and timely execution of batches. Preparation of BMR/MFR/ Scale-up report, containment approach and delay sheets. Initiation of Deviation, change control, RCA and Market compliance. Handling customer queries related to documents, process and equipment. Took a lead role in the Development of Technology development Lab. Identification of CPP and CQA. Identification of Gap from sending units and receiving units. Preparation of risk identification, Assessment and communication. Initiation of purchase order and purchase request for change parts. Preparation Technology transfer protocol and report. Preparation of Justification note for deviation and changes for customer approval.Regulatory Audits Faced - TGA, ANVISA, PMDA, USFDACustomer Audits- GSK, Bluefish Pharmaceuticals, SANOFI, JAMPAchievements: Best employee of the month and Star performerTraining coordinator in Technology, machines and Process. Show less

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  Biocon

  Nov 2022 - now

  Assistant Manager

  Product developmentcomplex injections include Cartridge, PFS and vial line.Regulatory query response.Timely execution of projects and updation.AVD and CIP lead with molecules to market.Filter validation and E&L studies.CRO and CMO handling.