Job Description Key responsibilities Support the maintenance and continuous improvement of the Quality Management System (QMS) QA inspection and release of incoming and raw materials and printed materials. Includes the maintenance of corresponding raw material specifications. Review production batch process sheets and final product documentation as part of the product release Timely issue of batch process sheets Support compliance with the quality management system and certification requirements (e.g. ISO 9001, ISO 13485, APVMA, DAFF, BICON etc.). Support the timely assessment and management of product, operational or quality related issues, i.e. product non-conformances, customer complaints, investigations, CAPAs, deviations and change controls. Assist with the management and maintenance of the document control and training systems. About you You’re organised, proactive and comfortable working in a regulated environment. You enjoy collaborating across teams and take pride in maintaining high Quality standards. You’ll bring: Bachelor of Science (or equivalent experience) 3 years’ experience in a Quality, regulatory, or compliance role within pharmaceutical, medical device, or veterinary manufacturing Experience working in a GMP environment (e.g. TGA, APVMA) Experience with Quality Management Systems Strong communication and interpersonal skills Solid MS Word and Excel capability Highly regarded: ISO 13485 experience Experience with biological or diagnostic manufacturing Auditor or training qualifications / experience Executing validation protocols, including cleaning validations Technical writing skills Why join AsureQuality Diagnostics? Work in a leading contract manufacturer and distributor of veterinary and medical diagnostic kits and speciality products Be part of a collaborative and dynamic team of experts Make a real impact on quality, compliance and continuous improvement
