Validation Manager at PT Daewoong Pharmaceutical Indonesia (2026-04 – Present)
- Direct the validation department, strategically establishing and monitoring cross-functional calibration, qualification, and validation activities in absolute compliance with the newest GMP requirements, ISO standards, and health authority regulations.
- Formulate, execute, and dynamically maintain the site's Validation Master Plan (VMP) and associated lifecycle schedules to guarantee fully compliant and audit-ready site operations.
- Manage deep departmental involvement in the preparation for ISO Integrated Management System (IMS) certification, focusing on Quality Management (ISO 9001:2015), Environmental Management (ISO 14001:2015), and Occupational Health and Safety (ISO 45001:2018).
- Establish, review, and modernize core Standard Operating Procedures (SOPs) and Work Instructions within the department to systematically minimize data integrity risks and document lifecycle failures.
- Partner proactively with Production, QA, QC, and Engineering to deliver critical site milestones and introduce data-driven continuous improvement frameworks.
- High-Impact Executive Achievement (Calibration Cost Optimization): Successfully identified and eliminated redundant external calibration parameters, substituting them with high-standard Internal Performance Qualifications to save an aggregate IDR 22,995,000 (approx. KRW 1,962,491).
- High-Impact Executive Achievement (Environmental Sampling Efficiency): Decreased environmental monitoring sampling frequency by applying a new risk-based PQ HVAC sampling approach derived directly from BioPhorum guidelines, significantly shrinking operational overhead.
Quality Assurance Manager at PT Fahrenheit Synthon Pharma (2022-01 – 2026-03)
- Directed and scaled the Quality Assurance Department (1 supervisor and 2 staff members) to orchestrate end-to-end quality assurance, quality management, and CQV for a high-complexity greenfield manufacturing expansion project.
- Built the entire QMS architecture and validation lifecycle workflows from scratch for a brand-new, state-of-the-art oncology manufacturing greenfield project, defining operational readiness.
- Authored the foundational corporate Quality Policy, Quality Manual, Site Master File (SMF), and Validation Master Plan (VMP) for the site.
- Formulated comprehensive QMS documentation control systems, covering Change Management, Deviations, and Training Management.
- Guided the executive board in successfully specifying and setting up the advanced Quality Control analytical laboratory.
- High-Impact Executive Achievement (Regulatory Approvals): Successfully spearheaded the plant implementation and validation readiness team to secure the official BPOM GMP Certificate with zero critical findings under a single cycle of CAPA review.
- High-Impact Executive Achievement (Dossier Development): Strategically collaborated with the product development groups to compile and clear critical technical dossiers, accelerating lines to final regulatory marketing authorization.
Quality Assurance Manager at PT Takeda Indonesia (2019-04 – 2021-12)
- Managed QA Operations and shop-floor oversight teams, leading 4 senior QA Specialists and 1 QA Administrator.
- Accountable for product batch reviews, raw material dispositions, and approving systemic investigations covering Deviations, OOS/OOT, and product complaints.
- Supervised Product Quality Reviews (PQR), performed systematic Quality Risk Management (QRM), and directed site mock recalls.
- Served as the primary site QA Subject Matter Expert (SME) for corporate validation frameworks and Data Integrity Remediation programs.
- High-Impact Executive Achievement: Restructured cross-functional releasing processes to systematically reduce batch release lead time from 3 days down to 1 day, significantly optimizing site supply chain supremacy.
Logistic Assistant Manager at PT Mersifarma TM (2018-08 – 2019-03)
- Commanded the full scale of Logistics operations (Warehouse & Dispensing), coordinating 2 supervisors, 4 coordinators, and a team of over 30 warehouse operators.
- Maintained rigorous warehouse control across raw materials, packaging components, finished goods, and required production supporting materials.
Validation Assistant Manager at PT Mahakam Beta Farma (2013-08 – 2018-06)
- Headed the plant-wide Validation Department composed of 2 supervisors, 3 senior staff, 5 inspectors, and 1 administrator.
- Oversaw all corporate calibration, equipment qualification, and manufacturing process/cleaning validations to meet strict GMP requirements.
- High-Impact Executive Achievement: Secured smooth, flawless GMP validation inspections for multiple site lines (solid dose, liquids, semisolids, cephalosporins, and sterile injectables), while achieving Grade A performance ratings for 4 consecutive years.
Quality Assurance Supervisor at PT Menarini Indria Laboratories (2012-11 – 2013-07)
- Handled day-to-day calibration, equipment qualification, and localized validation protocols at the factory floor to ensure regulatory alignment.
Quality Assurance Supervisor at PT Kalbe Farma (2011-01 – 2012-11)
- Managed process and cleaning validation activities, stability testing, Product Quality Review (PQR) reporting, and factory product complaint investigations.
- High-Impact Executive Achievement: Successfully optimized and updated the process validation standard, scaling its implementation across all group sister sites.
