About the role

The QA Associate is responsible for ensuring the safety and quality of components of manufactured medicines, both pre-and-post-production. This role requires excellent knowledge of TGA PIC’s guidelines, proficiency in Good Documentation Practices (GDP), with a keen focus on release for supply activities.

It is a diverse role covering all aspects of quality operations, such as sampling and inspection of incoming goods, environmental monitoring, document control, deviation investigations, auditing, training, data entry and trending.

This role is a full-time, onsite 12-month contract position

Key Responsibilities:

• Batch document review as a supporting function for RFS
• Issuing of Batch documentation to production
• Perform RO water sampling and Conductivity testing
• Organise monthly environmental monitoring with contract laboratory and maintain results on spreadsheet
• Monitoring Temperature data loggers, pressure differentials and scale daily checks
• Organise Raw materials and Finished goods samples for testing
• Raw material release and trend management
• Monitor raw materials expiry/retest dates and work with the warehouse to obtain samples for retest
• Perform Supplier reassessment activities
• Enter test results in ILAB system
• Conduct inspection and release of packaging components
• Maintenance of master artwork
• Change control
• Participate in the internal audit program
• Updating Standard Operating Procedures
• Performing deviation and CAPA investigations
• Maintain retention store for raw materials, components, and documentation
• Assist in maintenance of company training programs and assist with GMP training
• Ability to follow instructions from management

Desired Skills and Experience

About you

• Tertiary qualifications in a Science related discipline
• Pharmaceutical manufacturing background with minimum of 3-5 years’ experience
• Working knowledge and ability to interpret the Australian Code of GMP
• Proven experience with the following:
  • Batch document review and batch release
  • Documentation control
  • Change control
  • Internal auditing
  • Root cause analysis investigations & CAPA
  • Sampling and inspection of incoming materials
• A strong awareness of and commitment to safety management
• Time management, analytical and problem-solving skills
• Driven and energetic personality
• High level of attention to detail, initiative, and strong work ethic
• Ability to work with all levels of the organisation from shop floor to senior management
• Strong communication skills both written and verbal
• Commitment to Continuous Improvement
• Sound working knowledge of Microsoft Word, Excel, PowerPoint, Outlook, MRP and/or ERP systems
•