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
- Youre organised proactive and comfortable working in a regulated environment. You enjoy collaborating across teams and take pride in maintaining high Quality standards.
Youll 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
Qualifications :
Tertiary Qualification in Science with experience in a GMP Manufacturing environment.
Remote Work :
No
Employment Type :
Full-time
Key responsibilitiesSupport 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...
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
- Youre organised proactive and comfortable working in a regulated environment. You enjoy collaborating across teams and take pride in maintaining high Quality standards.
Youll 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
Qualifications :
Tertiary Qualification in Science with experience in a GMP Manufacturing environment.
Remote Work :
No
Employment Type :
Full-time
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