Numer Francisco Email & Phone Number

Tullamarine, Victoria, Australia

• Handle product batch releases by performing thorough quality reviews of batch documents and test results to meet department KPI• Develop, implement and maintain the site document management system by assisting in the preparation, review, issuance and control of Good Manufacturing Practice (GMP) documents such as Standard Operating Procedures (SOP) and specifications • Handle site wide internal auditing (Production, Logistics, Warehouse and QC Lab – GMP & OHS) and facilitate corrective and preventive actions and implement continuous improvement projects in line with company quality systems and policies• Monitor and report site quality metrics • Handle and investigate customer complaints, deviations and non-conformance repots by working closely with Sales, Production and QC Laboratory staff in preforming root causes • Conduct Trainings and maintain training and competency matrix • Handle change control / change management system by maintaining registers; participating in the review and completion of change proposals by discussing details with the change initiators • Handle Corrective Action / Preventive Action system by maintaining the register and following up deadlines and completions• Prepare product certificate of analysis as part of external customer requirements for local and export sales • Handle Annual Product Quality Review by reviewing large datasets and processing information about all the products made by the company and summarising into comprehensive reports comprising of test results, graphical presentations, investigations, recommendations and conclusions • Participate in Government Regulatory Audits and Third Party Audits by providing relevant documents for review and discussing issues of concern with auditors• Participate in reviewing new product development (packing & filling specifications, artwork requirements) by assessing items in line with regulatory guidelines • Manage company archives

• Review of batch release documentation to assure the safety, potency and efficacy of products• Review Standard Operating Procedures (SOP), Process Operating Instructions (POI) and test worksheets• Monitors product stability programme in line with regulatory requirements • Participate in materials quarantine and on hold process of materials • Performs internal auditing• Handles document control system for SOPs, worksheets and POIs.• Liaise with Production, QC, Warehouse and Logistics regarding product release• Release/Control products using BPCS• Manages and review process changes using Trackwise• Performs product material batch tracing• Monitors and administers GMP Training for the site• Prepares and issues documentation to start production• Prepares and issues quality documentation needed for exports

• Responsible in the industry data analysis and reporting and computation of value added contribution in the New Zealand Gross Domestic Product (GDP) • Contributes to the development of processes, procedures, methodologies and systems relevant to the work area, including preparation of appropriate documentation• Undertake the operational and technical aspects of processing information, data evaluation/data confrontation, report and interpret statistics for public use, develop projects, research and analysis in areas relevant to the work area• Understand the requirements of internal and external clients, and where applicable, liaise, communicate and provide assistance• Apply knowledge and maintain awareness of issues for providing advice in areas of expertise• Research conceptual and methodological issues and present recommendations and implement improvements• Contribute to the formulation and review of Statistics New Zealand policies, programs and strategies, or other corporate initiatives