rizalfauzan

Conducting projects to reduce raw material and bulk testing for the QA Department based on sample trend, COA, and MSDS. Coordination with Vice President, Quality Senior Manager, Quality Manager and Engineering Manager to conduct Quality Laboratory renovation project. Reviewed the results of HC, PC, and OC testing. Reviewed the logbook of activities in the Lab. Create or revise SOP, WI, Form as needed. Auditee for Everest, Haleon, Avoskin, ISO 9001, and ISO 14001 audits. Handle CAPA based on internal and external audit Handle training to internal quality department and others.

Coordination with QC Head to manage QC Microbiology division. Manage 13 subordinate in 3 work shift to handle QC and Production operation. 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. Handle training to internal quality department and others. Create Analytical Method Validation (AMV). Create water system and environmental monitoring quarter and annual trend. 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. Auditee for BPOM, KEMENKES, and WHO Building QC Microbiology sample management system. Builiding QC Microbiology stock opname system.

Quality Management System Manage CAPA BPOM & WHO audit Manage CAPA Bill and Melinda Gates Fondation audit Qualification production machine for production nOPV2 vaccine Qualification viable and non-viable environmental monitoring.

Analysis biocide on paper machine with cycle study method.

Plant anatomy & Physiology, Botany Cryptogamae & Phanerogamae, Animal Embryology & Morphology.