Key Duties and Responsibilities:

• Ensure ongoing compliance with relevant legislation governing the company's business and operations.
• Document steps of the required processes in company controlled procedures.
• Maintain accurate and detailed records of quality assurance, quality control and process operational activities.
• Assist in recording, investigating, resolving and trending quality issues
• Assist in inventory monitoring of critical process consumables, facilitate purchases and execute verification checks and release-for-use of incoming goods.
• Assist in facilitating and partaking in (where duties dictate) site training regimes.
• Assist in hosting internal, external and regulatory audits including formulating responses to deficiencies.
• Receive customer product for processing, perform quality verification checks and complete associated records.
• Initiate pre-programming irradiation recipes.
• Ensure appropriate labelling batches of customer product denoting the disposition.
• Ensure that all work is performed in accordance with the requirements of the Workplace Health & Safety Policy, procedures and legislation.
• Take reasonable care for own health & safety, as well as that of others.
• Compliance with all relevant safety practices including the reporting of hazards, near misses and incidents through safety system

Skills and Qualifications:

• Minimum 2-3 years' experience in quality function within a manufacturing, pharmaceutical, healthcare environment or other highly regulated industry.
• Sound understanding of Quality Management System requirement (preferably ISO9001 and/or ISO13485 and/or other highly regulated industry standard).
• Knowledge and experience in TGA Audits and/or other regulatory bodies.
• Sound judgment and decision-making abilities, often under pressure.
• Excellent communication skills.
• Solid level of attention to detail
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