Andrew Yu Email & Phone Number

Sydney, New South Wales, Australia

Sydney, New South Wales, Australia

Sydney, New South Wales, Australia

- Key contributor to the development of Uniting's Quality Management System including its Policy Framework, Risk Management Framework, Compliance Management Framework.- Developed, manage and continuously improve the organisation documentation management system on SharePoint Online used by over 10,000 staff.- Coordinate, review and ensure compliance of.

Sydney, Australia

• I ensure Pfizer site GMP and product quality/regulatory compliance with the standards set out by the TGA/Medsafe, other external markets and Pfizer Quality Standards.
• I prepare and review dossiers and technical reports for regulatory submissions for product launches and product updates (including CAT 1 and CAT 3 submissions).
• I initiate and create regulatory change records in the Pfizer global system.
• I am a Change Management Coordinator within the Pfizer Sydney site.
• I manage a product portfolio consisting of ethical, consumer and animal health products, each type requiring different regulatory standards. I routinely review and approve manufacturing /packaging instructions, test.
• I am a qualified Lead Auditor to conduct internal audits – I have conducted audits in high risk areas each year identifying areas of improvements which led to more compliant and robust operations.

Sydney, Australia

• I am a System Administrator and Site SME for LIMS, a laboratory information management system. My role included updating and improving the system, training users and troubleshooting system/ user issues.
• Additionally I carry out microbiological testing and review of environmental monitoring, raw material and production samples.
• I prepared, reviewed and maintained quality documentations relating to LIMS and microbiology procedural documentation.

Sydney, Australia

• I carried out microbiological testing and review of environmental monitoring, water and production samples.
• I performed environmental monitoring sampling of the production plant.
• I performed quality control testing and review of raw materials used for drug product production.