Quality Assurance Specialist
Professional ExperienceAstraZeneca Pharmaceutical - QA Officer- Provide required Quality support in New product launches.- Provide and create digital and technical innovation at Cikarang Site and local initiative in Quality area.- Support COVID-19 Vaccine management from a Quality perspective i.e. support in responding product quality complaint from BPOM and Indonesia Minister of Health- Perform gap analysis of global quality documents related complaint, training, product review, recall, data integrity and documentation, stability.- Manage Quality Management System: Complaint, Training, Product Review, Recall, Data Integrity and Document Control, Stability and Supplier/Vendor management.- Learning Management System administrator, manage training management in the system.- Participate in problem solving and review investigation of complaint issue from market.- Managing Recall Management including in executing periodic Mock Recall activities.- As frontperson for Regulatory Inspection, Internal Audit, and Self Inspection- Review batch record for release product.Achievement:- Power BI for Quality metrics: Complaint metrics visualization (2021Q4 Regional Lean Award: Cikarang site digital initiatives)- Lead Global deployment of EQV Program AZ Content Management (ECMS) and GPQS Complaint in Cikarang Site.- Lead Site deployment of Cornerstone SBX- ECMS Connector for training management system in Cikarang Site.- Digitalization for Flow Process to make document effective (Winner of Lean Award: Most Valuable idea 2020)- Lead Project of Simplification for Duplication and Design Logbook in Cikarang Site (reduce 14% logbooks and 17% paper saving).
