Job Description

Health and Aged Care Professionals - Sydney NSW

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2d ago , from Health and Aged Care Professionals

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- Permanent opportunity within an international pharmaceutical company
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- Broad role across both Regulatory Affairs and Quality Assurance
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- Work closely with local, regional and global stakeholders
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Benefits nn
- Permanent opportunity within an international pharmaceutical company
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- Broad role across both Regulatory Affairs and Quality Assurance
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- Work closely with local, regional and global stakeholders
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About the company n

A global pharmaceutical organisation with an established Australian presence and a strong commitment to quality, compliance and patient outcomes.

About the opportunity n

An exciting opportunity has become available for a Regulatory Affairs & Quality Associate to join a growing pharmaceutical organisation. This is a broad, hands-on role spanning both QA and RA activities. You will support the ongoing management of the QMS while also gaining exposure to regulatory submissions, product lifecycle activities, artwork and labelling, TGA requirements and GMP clearances.

Duties n

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- Support day-to-day Quality Management System activities including deviations, CAPAs, change controls, complaints and quality documentation
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- Assist with document control, SOPs, training records and continuous improvement activities
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- Support TGA GMP clearances, including applications, renewals, supporting documentation and tracking
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- Assist with supplier qualification, vendor compliance and quality agreements
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- Support batch release, product quality reviews, complaints,



recalls and quality investigations
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- Maintain regulatory dossiers, submission records and product-specific regulatory documentation
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- Support ARTG applications and preparation of regulatory submission documentation
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- Review product labels, artwork and packaging for regulatory compliance
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- Support product lifecycle activities including registrations, variations, renewals and regulatory approvals
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Skills and Experience nn
- Tertiary qualification in Pharmacy, Pharmaceutical Sciences, Life Sciences, Biotechnology, Chemistry, Microbiology or a related discipline
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- Experience within pharmaceutical Quality Assurance, Regulatory Affairs or a related environment
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- Understanding of GMP requirements and pharmaceutical quality systems
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- Exposure to QMS processes such as deviations, CAPAs, change controls or complaints would be highly regarded
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- Knowledge or exposure to TGA regulatory requirements would be advantageous
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- Experience within a pharmaceutical sponsor, manufacturer or distribution environment would be beneficial
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- Strong attention to detail and documentation skills
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- Excellent organisation and time management skills with the ability to manage competing priorities
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- Strong communication and stakeholder management skills
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- Ability to work independently while contributing effectively within a cross-functional team
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Culture n

Join a collaborative and quality-focused setting where you will work across multiple areas of the business and have the opportunity to broaden your Regulatory Affairs and Quality Assurance experience.

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📌 Regulatory Affairs & Quality AssociateNew (Sydney)
🏢 Health and Aged Care Professionals
📍 Sydney