• Specialise in Quality Management and Compliance and recommend appropriate validation approaches for Operations PCS, Lab Instruments and Regional / Local IT systems• Steer project and business teams from a regulatory compliance and quality management perspective, to meet company policies and government regulations.• Maintain proactive IT and business engagement and collaboration, to ensure Quality Management deliverables are aligned with customer expectations, IT strategy and meet the needs of the business.

Validation Lead for the Implementation of PAS-X (MES) system and ASIASAP (SAP ECC 6.0) including GQCLIMS and SMARTLAB (EM / LES) into the North Ryde Manufacturing Facility.

Manage the Document Administrator responsible for administrating the Electronic Documentation System. Support, encourage and coach the Document Management Administrator with personal development and perform regular performance reviews and appraisals. Resolve conflicts as required.• Advise departments (ISMO and Manufacturing) on compliance (GxP) and validation requirements for Computerised Systems including Infrastructure.• Perform Audits including Electronic Record and Electronic Signature assessments on Computerised Systems.• Evaluate and review validation requirements for new and legacy computerised systems including SAP (ECC 5.0)

Compliance and validation responsibilities / guidance for SAP (ERP) system implementation into five operation sites in Asia Pacific Region (incl. China, Japan, India, Indonesia, Eygpt)

Responsibilities• Reviewed developments in Computerised System Validation (CSV) guidance (cGMP and Corporate Guidelines) and evaluate current practices and procedures. Contributed to the development of AZA policies and approaches to CSV, highlighting areas for improvement in compliance.• Facilitated the development of Impact Assessments for systems, with input from stakeholders.• Catalogue and reviewed existing CSV deliverables for items on System Inventory listing.• Developed procedures for CSV activities and reviewed and defined Validation Templates in line with SOPs.• Assisted in the training of stakeholders with responsibilities for Computer Systems Validation activities.• Audit Computerised Systems against Annex 11 (Code of cGMP) and site CSV SOPs.• Contributed to the performance of CSV activities within specific projects. Responsibilities included: Validation Planning Supplier Auditing Impact Assessment Risk Assessment Write / Review Specification Supplier Monitoring Testing and Documentation Validation Reporting Change Control Conduct  System Retirement Management

Responsibilities• Audited Processes and Procedures against the code of GMP. Wrote audit reports and debriefed; following up on any non-compliance issues.• Conducted gap analysis between internal and external documentation that affects AstraZeneca procedure. Prepared reports on findings and made recommendations.• Provided and maintained documentation on relevant Quality Systems.• Maintained the Quality management (Quality Notifications) module of SAP. Reviewed and analysed the Quality Notification process for potential weaknesses and improvements.• Provided support to the Quality Notification System Administrator and other staff when required. Provided training when required and maintained the on-line help function in QM using MS FrontPage.• Implemented new Quality Projects when required. • Provided support and GMP guidance to other projects when required.• Managed QA Change Controls and ensured all computerised changes met cGAMP standards.Significant Achievements• Implemented Automatic Usage Decisions for packaging materials including Project Management and Validation deliverables. Provided training of the new system. This system reduced the time required to process Results Recording for packaging materials allowing a Usage Decision to be made by the system based on a set criteria.

Responsibilities• Investigated Quality Issues in Production. Facilitated meetings, reviewed, wrote reports, implemented Corrective actions and monitored.• Investigated Customer Complaints from local and export markets.• Supported and assessed trainee auditors through the auditing process from planning to debrief.• Audited against the code of GMP site processes and procedures including the writing of audit reports and debrief; following up on any non-compliance issues.• Conducted gap analysis between internal and external documentation that effects AstraZeneca procedure. Prepared report on findings and made recommendations.• Provided and maintained documentation on relevant Quality Systems.• Maintained and administrated the Quality Database (MS Access) for Quality Audits and deviations.Significant Achievements• Implemented the Quality Notification module of SAP including Project Management and Validation deliverables. This system provided a significant improvement in the management and reporting of Deviations raised during the manufacturing process.

Responsibilities• Managed SOP files (File Administrator) and Maintained departmental lists.• Conducted internal housekeeping audits for the Engineering department.• Developed and implemented systems that ensure consistent and accurate customer feedback which was utilised to improve customer services. Developed a computerised based customer survey for the Engineering Department.• Facilitated Contractor Inductions.• Wrote reports, faxes, letters and memos for the Engineering Department.• Provided System support for SAP R/3 including MRP (Purchase requisitions / Purchase Orders) and stock control for Engineering Spares.• Monitored, assisted and followed up on budgets.• Assisted with Validation and change control for the Engineering Department.Significant Achievements• Successfully created and maintained the Calibration Plans and equipment in SAP system that is still being used today. Thus removing the need for a paper based system. This increased efficiency and turnaround time in completing calibration activities.