Experience

Sphere Healthcare Pty Ltd

• Australia
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Continuouse Improvement Auditor

  • Apr 2015 - Present

  Examine and evaluate the adequacy, effectiveness and efficiency of the organisation's internal control system and procedures and recommend corrective actions to improve operations, quality and regulatory compliance. Examine and evaluate the adequacy, effectiveness and efficiency of the organisation's internal control system and procedures and recommend corrective actions to improve operations, quality and regulatory compliance.



Homart Pharmaceuticals Pty Ltd

• Australia
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Technical Manager

  • Nov 2014 - Apr 2015

  Coordinate the activities within the Manufacturing and Quality Department to manage production schedules ensuring the highest quality standards, and safety issues. Communicate with all relevant inter- company contacts; provide adequate information, consult the appropriate persons in case of problems and contribute to the decision making process. Supervise together with the Quality department production activities to ensure GMP compliance Coordinate the activities within the Manufacturing and Quality Department to manage production schedules ensuring the highest quality standards, and safety issues. Communicate with all relevant inter- company contacts; provide adequate information, consult the appropriate persons in case of problems and contribute to the decision making process. Supervise together with the Quality department production activities to ensure GMP compliance



Ferngrove Pharmaceuticals Pty. Ltd.

• Australia
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality Assurance Manager

  • Mar 2012 - Nov 2014

  Monitor and liaise with other managers and staff throughout the organisation to ensure that the quality management system is functioning properly, Ensure that the product or service provided are consistent and meets both external and internal requirements, Ensure that the rules of Good Manufacturing Practice a understood and applied across all levels of organisation, Assess customer requirements and ensure that these are met, Determine, negotiate and agree on in-house quality procedures, standards and specifications, Ensuring that manufacturing processes comply with standards at both national and international level, Working with operating staff to establish procedures and standards, Monitor performance and determine training needs, Specified quality requirements of raw materials with suppliers, Advise on changes and how to implement them to achieve quality, compliance and customer expectations. Manage and improve the documentation program (CAPA, Change Control, Deviation process, Re-work Product Quality Review , Risk Management , SOPs , Internal and External Audits) Develop and monitor the Food System Program -HACCP plan for Infant Formula Support TGA, APVMA, AQIS and NSW Food Authorities.



Jalco

• United States
• Business Consulting and Services
• 1 - 100 Employee

• Regulatory Affairs

  • 2011 - 2012

  Ensure the appropriate licensing, marketing and legal compliance of pharmaceutical and medical products in order to control the safety and efficacy of products. Compile and prepare materials for submissions to the regulatory agencies.(TGA/APVMA/AQIS/NSW Food Authorities)

• Laboratory Manager

  • 2005 - 2011

  Take responsibility for managing the daily operations of the lab. Take responsibilities for all aspects of the lab, including but not limited to: instruments/equipment,SOP, Test methods,Safety, Training, RM specifications, compliance with standards and TGA regulations.