Sheila Pratiwi

Experience

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  IPSF Asia Pacific Regional Office (IPSF APRO)

  Jan 2014 - Jan 2016

  Design Subcommittee
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  Universitas Padjadjaran

  Jul 2015 - Dec 2015

  Laboratory Assistant
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  Rumah Sakit Umum Daerah Kota Bandung

  Jul 2017 - Jul 2017

  Internship
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  Bayer Pharmaceuticals

  Aug 2017 - Sept 2017

  Quality Control Intern
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  PT. Kimia Farma Apotek

  Oct 2017 - Oct 2017

  Internship
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  PT Kalbe Farma, Tbk

  Apr 2018 - Oct 2025

  1. Monthly analyze compliance data for Best Quality Data and Productivity, Document, and Compliance (PDC)2. Maintain more than 1500 controlled procedures and company records from all departments (preparation, approval, distribution, destruction, monitoring, simplification, periodic review)3. Succesfully submit the quality document for regulatory authorities on time (no overdue since 2023)4. Daily in charge of all registered documents in Kalbe Farma (Document Management System)5. Ensure all departments using the most updated logbooks & other quality worksheets (WHO standard)6. Lead team for continuous Improvement (SS, QCC)7. Manage change control implementation for any improved / new controlled procedures8. Cooperate with related departments to perform quality campaign (document and data integrity related)9. Analyze any gap from WHO TRS and other regulations for documentation and data integrity related scope10. Review and register more than 200 routine Quality Risk Management documents from all departments11. Review all the activities held in Kalbe related to data integrity and good documentation practice Show less In Charge of :1. Site Master File2. CAPA Handling and Monitoring (ISO 9001, ISO 14001, ISO 45001, WHO, KCQM, KCQG, CPOB, CPOTB, Halal)3. Internal and External Audits (Self Inspection, Halal, ISO [SGS], WHO, FDA)4. Gap Analysis (CPOB, CPOTB, KCQM, KCQG, Halal, PQ WHO)5. Quality Department KPI Bank Data6. QRM and ERM Review and Monitoring7. Quality Departments (QC, QA, QS) KPI Reports to Corporate and Other Related Departments8. GMP Document Deviation Handling and Monitoring9. SOP and Company Procedure Review Show less In charge of :1. Regulatory Compliance (BPOM, ISO 9001, CPOB, CPOTB, WHO, FDA)2. Analytical Methods and Specifications for Marketed Product Laboratory Testing (Raw Material, Packaging Material, Finished Good Products)3. QC Documents Controller4. Quality Document Submission for Regulatory Authorities5. Document Management System6. QC KPI Monitoring7. All QC Monthly Reports (Raw Material, Packaging Material, Finished Good Products, Microbiology, Product Stability)8. Packaging Material Document Development (AQL, AVL, Proof Print, Color Range)9. Logbooks & Other Quality Worksheets (WHO based)10. Continuous Improvement (SS, QCC) Show less

  • Quality Assurance Supervisor

    Jan 2025 - Oct 2025

  • Quality System Supervisor

    Feb 2023 - Jan 2025

  • Compliance Quality System Supervisor

    Sept 2021 - Jan 2023

  • Document Control QC Supervisor

    Apr 2018 - Aug 2021
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  Pharmaceutical Company

  Oct 2025 - now

  System Compliance