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Miten Vyasa

Miten Vyasa

Private tutor

Followers of Miten Vyasa3000 followers
location of Miten VyasaAhmedabad, Gujarat, India

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  • Timeline

  • About me

    Regulatory Affairs/ CMC / US Market / Post Approval RA / Commercial RA / Process Validation, Cleaning Validation & Verification, New Product Validation, Equipment Qualification, QMS, Data Integrity, CAPA, Deviation, OOS

  • Education

    • K.B.Institute of Pharmaceutical Education and Research ( Kbiper )

      2012 - 2014
      M.Pharm Quality Assurance distiction

      Activities and Societies: in teacher's day celebration as well enjoyed fresher's party as well as most active person in my batch learnt what is quality assurance and its importance

    • Sharda school of pharmacy

      2008 - 2012
      B.pharm Pharmacy Distiction

      Activities and Societies: Presented 2 posters at Parul college of pharmacy learnt pharmacy

    • Jivkorbai lallubhai high school

      2005 - 2008
      12th science Distiction

      Activities and Societies: Participated in various Science based activities. Participated in Drawing competiton Participated in National Level Drawing classes learning science subject very well

  • Experience

    • Home

      Mar 2012 - Apr 2012
      Private tutor

      Taught Physics of 12th science

    • Manish Pharma Lab

      Apr 2014 - Aug 2014
      Junior Executive in QA department

      Raw Material handlingFinished Product handlingVarious IPQC testsDocumentationProduct and raw material releaseHandling of Working standards

    • Claris Injectables Limited

      Aug 2014 - Aug 2017

      Various Validation Activities on Manufacturing Process Like Mixing Validation, Washing Validation, Filling Validation, Capping Validation, Sterilization Validation Etc.Qualification of Equipments.Calibration of InstrumentsVery Good Hand on HPLC, UV, AAS, Kaye Validator, Valprobe Reader, Malvern Master Sizer, Microscope Etc. Knowledge about Quality by Design ApproachKnowledge about Matrixing Approach in Process ValidationPreparation of protocols for various validation activities.Faces US-FDA, ANVISA and various other regulatory audits.Performed various activities regarding quearies and market complaints Show less Various Validation Activities on Manufacturing Process Like Mixing Validation, Washing Validation, Filling Validation, Capping Validation, Sterilization Validation Etc.Qualification of Equipments.Calibration of InstrumentsAnalysis of Validation SamplesVery Good Hand on HPLC, UV, AAS, Kaye Validator, Valprobe Reader, Malvern Master Sizer, Microscope Etc. Knowledge about Quality by Design ApproachKnowledge about Matrixing Approach in Process ValidationPreparation of protocols for various validation activities.Faces US-FDA, ANVISA and various other regulatory audits.Performed various activities regarding quearies and market complaints Show less

      • Jr. Executive QA Validation & Qualification

        Aug 2015 - Aug 2017

      • Sr. Officer - QA ( Process Validation )

        Aug 2014 - Aug 2015

    • Baxter International Inc.

      Aug 2017 - Feb 2018
      Jr. Executive - QA Process Validation and Qualification

    • Puniska Healthcare Pvt. Ltd.

      Mar 2018 - Nov 2021

      Validation and Qualification Area.

      • Senior Executive

        Nov 2019 - Nov 2021

      • Executive - Qualification and Process Validation

        Mar 2018 - Nov 2019

    • Amneal Pharmaceuticals

      Nov 2021 - Dec 2022
      Sr. Executive - Validation

    • Nivagen Pharmaceuticals, Inc.

      Dec 2022 - now
      Sr. Executive - Regulatory affairs

  • Licenses & Certifications

    • Developing Your Emotional Intelligence

      LinkedIn
      Nov 2022
      View certificate certificate

    • Project Management: Healthcare Projects

      LinkedIn
      Nov 2022
      View certificate certificate

    • Reduce Stress and Anxiety by Managing Your Nervous System

      LinkedIn
      Nov 2022
      View certificate certificate

    • Speaking Confidently and Effectively

      LinkedIn
      Nov 2022
      View certificate certificate

    • The Six Morning Habits of High Performers

      LinkedIn
      Nov 2022
      View certificate certificate

    • CGMP: Introduction to Good Manufacturing Practice - An Abridged Course

      Biopharma Institute
      Aug 2021

    • CAPM

      Simplilearn
      Aug 2021
      View certificate certificate

    • Elearning: Foundation of GMP: Heating, Ventilation and Air Conditioning (HVAC) System

      USAID
      Aug 2021

    • Introduction to Project Management

      Simplilearn
      Jul 2021
      View certificate certificate

    • Strategic Thinking

      LinkedIn
      Mar 2021
      View certificate certificate

  • Volunteer Experience

    • volunteer

      Issued by QA - THE NGO on Apr 2014
      QA - THE NGOAssociated with Miten Vyasa