Improvement comes from IDEAS
Specialized in ISO and MDR certification
Experienced Project Manager, Quality Specialist and Biocompatibility Expert provide advices to improve product and process cycle. With an extensive experience for over 15 years in Quality and Regulatory including Biocompatibility Expert, End to End Q&R Transformational Programs, Quality Assurance, Quality Control, Quality System Improvement, Quality Compliance, Quality Management System, Research & Development, Supply Chain Management in multinational companies such as Storteboom, Mead Johnson/ Reckitt Benckiser, Merck Sharp Dohme, Philips, Indonesian FDA and currently Elekta.
Certified Lean Six Sigma Black Belt and experienced in Scrum Master for Non-Software, experienced in EU-MDD and EU-MDR, GMP, ISO 10993:2018, ISO 14971, ISO 13485:2012, Internal Auditor for ISO 9001:2015 Quality Management System and ISO 17025:2015, bachelor’s in pharmacy, Pharmacist, Master Quality Management System.
PROJECTS
MSD Quality Project Leader
- Lead deployment and implementation of QMS at MSD Biotech Oss, perform gap assessment against Global QMS, ICH Q7 and ICH Q10 (GMP)
- Lead project improvement for primary packaging (GLP) Transfer the distribution process from internal-warehouse to an external-warehouse (GDP)
Philips QMS Business Process Expert
- Lead deployment of global
Philips QMS within Philips business unit world-wide - Collaborate and support
Directors and Managers Q&R during QMS transformation program ISO 13485 - Manage E2E Programs and
business / market PQMS teams
Elekta Biocompatibility Expert
- Lead, monitor and provide
pragmatic strategy for biocompatibility - Establish, evaluate, and
improve product & process cycle, standardized procedures in compliance with ISO 10993, ISO 14971 and ISO 13485 - Perform gap assessment on
ISO 13485, EU-MDR, write BER, CER, Technical File
SERVICES
Roles
Project Manager
Quality Specialist
Quality Assurance Specialist
Quality System
Biocompatibility Expert
Regulatory Affairs
Coaching
R&D Experts
Product and Process Development
Skills
Gap analyses
Project Management
Business Process Improvement
Risk Assessment
Risk Management, Biocompatibility
Biological Evaluation Report
Clinical Evaluation Report
Chemical Characterization
Laboratory experience for more than 10 years
Standards/Tools
ISO 13485:2012
ISO 10993:2018
ISO 14971:2019
ISO 9001:2015
ISO 14001:2004
ISO 17025
ICH Q7, ICH Q10, GMP, GLP, GDP, GXP
SAP, GCM, Trackwise, Quest, GLIMS, Enovia, MIDAS, Master Control, Polarion
