Bintang Gustami

QA Supervisor at PT Finusolprima Farma Internasional (a Kalbe Company)
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Contact Information
us****@****om
(386) 825-5501
Location
West Java, Indonesia, ID

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Experience

    • Indonesia
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • QA Supervisor
      • Jun 2022 - Present

      QA csv-change control -perform computerized system validation (clsm) -conduct data integrity assessments related to csv -create and monitor quality risk management related to machine-building-utility area -perform and review implementation change management (pic change control) QA csv-change control -perform computerized system validation (clsm) -conduct data integrity assessments related to csv -create and monitor quality risk management related to machine-building-utility area -perform and review implementation change management (pic change control)

    • Chemical Manufacturing
    • 700 & Above Employee
    • IPC Pharmacist
      • Apr 2021 - Apr 2022

      -Handling and create IPC report during production and packaging process -Perform line clearance and ensure all the process meet spec, internal standard, and GMP -Reviewing batch record, in process control related -Supporting validation and investigation activity in operation -Handling and create IPC report during production and packaging process -Perform line clearance and ensure all the process meet spec, internal standard, and GMP -Reviewing batch record, in process control related -Supporting validation and investigation activity in operation

    • Quality Assurance Validation Officer
      • Sep 2019 - Apr 2021

      -Reporting to QA Validation-TS Spv -Create and manage execution of cleaning validation protocol-report activity in solid and softgel dossage form -Responsible to create trend of Environmental Monitoring (HVAC,Compressed air, and Purified water) in pharmaceutical industry -Handling and create UAT report for Computerized system validation -Handling some project qualification of softgel machines -Reporting to QA Validation-TS Spv -Create and manage execution of cleaning validation protocol-report activity in solid and softgel dossage form -Responsible to create trend of Environmental Monitoring (HVAC,Compressed air, and Purified water) in pharmaceutical industry -Handling and create UAT report for Computerized system validation -Handling some project qualification of softgel machines

    • Indonesia
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Student Internship
      • Jan 2019 - Feb 2019

      This is an internship program during my study at professional degree of aphotecary, Airlangga University. It's just only 1 month. My responsibilities during this program is: Helping on the pharmacist counter (Apotek Kimia Farma 23 Surabaya), giving a pharmaceutical care, and dispensing medications. This project's focus especially in comunity pharmacy field. This is an internship program during my study at professional degree of aphotecary, Airlangga University. It's just only 1 month. My responsibilities during this program is: Helping on the pharmacist counter (Apotek Kimia Farma 23 Surabaya), giving a pharmaceutical care, and dispensing medications. This project's focus especially in comunity pharmacy field.

    • Indonesia
    • Pharmaceutical Manufacturing
    • 500 - 600 Employee
    • Internship
      • Oct 2018 - Nov 2018

      Only 1.5 month because of requirement of graduation on apothecary professional degree in my campus. My responsibilities during internship was helping on data integrity project of Quality Control, i.e. : -documentation in quality control department -data integrity using computerization system by shimadzu Only 1.5 month because of requirement of graduation on apothecary professional degree in my campus. My responsibilities during internship was helping on data integrity project of Quality Control, i.e. : -documentation in quality control department -data integrity using computerization system by shimadzu

Education

  • UNAIR
    Pharmacist
    2018 - 2019
  • UNAIR
    Bachelor of Pharmacy - BPharm, Farmasi Industri dan Ilmu Kosmetik
    2014 - 2018

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