Serialization and Packaging Engineer - Freelance

• Jan 2022 - Present

Senior Serialization and Validation Consultant

• Aug 2014 - Dec 2021

Key Responsibilities: - Defining the serialization system implementation strategy - Supporting the client for the system vendor selection - Actively participate on authoring and review phase of the validation & qualification deliverables - Prepare and execute system qualification protocols and testing documentation and reports - Provide and maintain serialization training for operational stakeholders - Author serialization procedures, work instructions, standards, and policies - Develop, maintain serialization data communication standards and implementations with supply chain partners Show less

Senior Validation Consultant

• May 2004 - Aug 2014

Key Responsibilities - System validation management by governing computer systems regulations and control such as FDA’s 21 CFR Part 11, EMA’s Annex 11, GAMP 5, and MHRA’s data integrity guidance - Determine validation plan for computer systems and automation systems - Create & review risk analysis - Monitor quality in all department and ensure compliance with all regulation - Participate in the development and implementation of standard template to ensure effective CSV - Participate in approvals of user and functional requirements for new and existing computer systems subject to validation - Execute QA reviews and approvals of all validation related documentation (IQ, OQ, PQ, URS and Traceability Matrix) - Execute system testing - Develop validation protocol and summary report - Ensure that the project follows relevant quality regulations - Establish good and close working relationship with project stakeholders and internal customers - Change Management - SOP Preparation - Business Analysis - User Training Show less