PT Etana Biotechnologies IndonesiaQuality Microbiologist
Feb. 2021 - Jul. 2024Jakarta Metropolitan Area- Qualified routine sampling of water system utility: purified water, water for injection, pure steam. - Qualified cleanroom viable environmental monitoring (Grade A, B, C, and D) for Routine, Performance Qualification, and Production process.
- Qualified microbiology testing: bioburden, limit test, endotoxin test gel cloth and kinetic chromogenic, swab finger test, growth promotion test.
- Qualified microorganism identification with gram staining, BBL, API, VITEX 2 Compact.
- Qualified sampler for IPC Trial, Engineering run, Media fill, Process validation, and Commercial batch.
- Qualified sampler for Cleaning validation.
- Gowning qualification B and C cleanroom grade.
- Create and handle document of QC Microbiology Division: SOP, quality trend for microbiology division
- Handle PR-PO for QC Microbiology Division.
- Handle and assist OOS, OOT, and CAPA.
- Create Analytical Method Validation (AMV).
- Create water system and environmental monitoring trend data.
- Perform QC Microbiology study and project: QC renovation, in-house prepared media, optimizing gowning qualification.
- Project PIC (IPC and viable monitoring): Bevacizumab Biosimilar, COVID-19 mRNA, Epoetin Alfa, Enoxaparin, PCV-13 single dose, PCV-13 multiple dose, COVID-19 mRNA 2nd Gen.
- Managed overall laboratory functions.
- Manage QC Microbiology sample management system.
- Manage QC Microbiology 5S