Mimi V S

Mimi v s

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location of Mimi V SJakarta, Indonesia
Followers of Mimi V S677 followers
  • Timeline

  • About me

    Pharmacist - Pharmaceutical and Chemical Industrial Practices | QA/QC | QA/RA | CSV | GXP | Quality Operation | QMS | PMO | Technology Transfer | QA/RA | Quality Auditor | Validation | Qualification

  • Education

    • University of indonesia

      1999 - 2000
      Apothecary (pharmacist) professional program

      1 Year Pharmacist Professional Program

    • Trinity college dublin

      2013 - 2016
      Master of science - ms pharmaceutical technology

      Part Time Pharmaceutical Technology Master and Qualified Person (QP) Program

    • University of indonesia

      1994 - 1999
      Bachelor's degree pharmacy
    • National university of singapore

      2009 - 2012
      Qa/ra post graduate program

      Pharmaceutical Manufacturing I / Drug Development ProgramModule :- FDA LAW- Regulatory Compliance- Regulatory Science- Drug Development

    • Atlantic technological university

      2021 - 2022
      Biopharmaceutical science

      L9 - Certified Biopharmacuetical Science (1 year Program)

  • Experience

    • Mitra keluarga

      Sept 2000 - Jan 2001
      Hospital pharmacist

      Manage day-to-day operation at Pharmacy Unit. Supervise Pharmacist Assistant; Provided information and consultation as hospital pharmacist; managing drug and medical devices stock of polyclinic, ICU, Radiology Room, Laboratory, and Surgery Rooms and Installation Pharmacy

    • Bristol myers squibb

      Feb 2001 - Aug 2007
      Qa section head

      Responsible for overall Quality System, QA Compliance, managing investigation of quality incident, handling complaint, and managing QA routine activity, such as IPC, Product and Material release, retained sample and batch record review.Various Position :- Manufacturing Technologist- Validation Specialist- QA Investigator Supervisor- QA Compliance Supervisor- QA Section Head

    • Novartis

      Sept 2007 - Sept 2012
      Site regulatory facilitator

      Manage and facilitate all on-site regulatory CMC related launch and post-approval activities (post-approval changes, transfers, remediation, divestment, pruning and due diligence) of the site specific (global and local) products to ensure timely supply to the markets in compliance with current regulatory obligations and requirements.Various positions:- QA Release Engineer- Process Validation and Product Transfer- Site Change Coordinator- Site Regulatory Facilitator

    • Givaudan

      Oct 2012 - Oct 2014
      Head of qmi south east asia

      • Lead local QMI Team in Singapore and Indonesia and Manage Talent• Management Representative of ISO Quality Management System• Oversight shop floor quality compliance and efficiency/improvement program.• Oversight Quality and Food Safety programs aligned with global policy• Overview Vendor and Customer Quality Programs aligned with global policies

    • Boehringer ingelheim

      Oct 2014 - Dec 2024

      Local lead for managing Site Strategy Projects of Boehringer Ingelheim Site Bogor Indonesia for smooth and successful site divestiture project that covering 1. Carve out and archiving in alignment with legal, IT and Merger and Acquisition (M&A) workstreams2. Technology transfer (Analytical method transfer and Product Transfer) during transition period.3. Ensure smooth site closure and handover in accordance to defined agreement. • Managing Quality System, QA, Validation/Qualification, Supplier Management and QC Laboratory• Drive for Compliance Enhancement and Improvement in Quality Operation Department and Site level• Business partner to support optimization and productivity• Develop and manage QO talent

      • Head of Site Strategy Project

        Jan 2024 - Dec 2024
      • Head of Quality Operation

        Oct 2014 - Dec 2023
    • Anugerah amartha global

      Jan 2025 - now
      Head of quality operations

      Managing Quality Compliance, Validation/Qualification, Quality Control and Technology Transfer

  • Licenses & Certifications

    • Chinese characters for beginner (2) 汉字(2)

      Coursera course certificates - peking university
      View certificate certificate
    • Chinese characters for beginner 汉字

      Coursera course certificates - peking university
      View certificate certificate
    • Chinese for beginner

      Coursera course certificates - peking university
      View certificate certificate
    • Level 3: critical thinking & advance auditing for data integrity: current perspective for compliance

      Green mountain quality assurance, llc
      Oct 2021
    • Level 2: data integrity governance programs - advance topic & train-the-trainer : current perspective for compliance

      Green mountain quality assurance, llc
      Mar 2021
    • Business analytics: decision making using data

      University of cambridge - judge business school
      Jan 2021
    • Level 1: data integrity assurance & investigation of electronic data & computerized system : current perspective for us fda compliance

      Green mountain quality assurance, llc
      Nov 2020
    • Finance for non-financial professionals

      University of california, irvine division of continuing education
      Jun 2022
      View certificate certificate
    • Chinese for hsk 1

      Coursera
      Apr 2022
      View certificate certificate