
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 - 2000Apothecary (pharmacist) professional program1 Year Pharmacist Professional Program

Trinity college dublin
2013 - 2016Master of science - ms pharmaceutical technologyPart Time Pharmaceutical Technology Master and Qualified Person (QP) Program

University of indonesia
1994 - 1999Bachelor's degree pharmacy
National university of singapore
2009 - 2012Qa/ra post graduate programPharmaceutical Manufacturing I / Drug Development ProgramModule :- FDA LAW- Regulatory Compliance- Regulatory Science- Drug Development

Atlantic technological university
2021 - 2022Biopharmaceutical scienceL9 - Certified Biopharmacuetical Science (1 year Program)
Experience

Mitra keluarga
Sept 2000 - Jan 2001Hospital pharmacistManage 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 2007Qa section headResponsible 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 2012Site regulatory facilitatorManage 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 2014Head 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 2024Local 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 2024Head of Quality Operation
Oct 2014 - Dec 2023

Anugerah amartha global
Jan 2025 - nowHead of quality operationsManaging Quality Compliance, Validation/Qualification, Quality Control and Technology Transfer
Licenses & Certifications
- View certificate

Chinese characters for beginner (2) 汉字(2)
Coursera course certificates - peking university - View certificate

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

Chinese for beginner
Coursera course certificates - peking university 
Level 3: critical thinking & advance auditing for data integrity: current perspective for compliance
Green mountain quality assurance, llcOct 2021
Level 2: data integrity governance programs - advance topic & train-the-trainer : current perspective for compliance
Green mountain quality assurance, llcMar 2021
Business analytics: decision making using data
University of cambridge - judge business schoolJan 2021
Level 1: data integrity assurance & investigation of electronic data & computerized system : current perspective for us fda compliance
Green mountain quality assurance, llcNov 2020- View certificate

Finance for non-financial professionals
University of california, irvine division of continuing educationJun 2022 - View certificate

Chinese for hsk 1
CourseraApr 2022
Languages
- enEnglish
- inIndonesian
- geGermanic languages
- chChinese
- maMalay
- arArabic
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