Health and Aged Care Professionals - Sydney NSW2d ago , from Health and Aged Care ProfessionalsPermanent opportunity within an international pharmaceutical companyBroad role across both Regulatory Affairs and Quality AssuranceWork closely with local, regional and global stakeholdersBenefitsPermanent opportunity within an international pharmaceutical companyBroad role across both Regulatory Affairs and Quality AssuranceWork closely with local, regional and global stakeholdersAbout the companyA global pharmaceutical organisation with an established Australian presence and a robust commitment to quality, compliance and patient outcomes.About the opportunityAn 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.DutiesSupport day-to-day Quality Management System activities including deviations, CAPAs, change controls, complaints and quality documentationAssist with document control, SOPs, training records and continuous improvement activitiesSupport TGA GMP clearances, including applications, renewals, supporting documentation and trackingAssist with supplier qualification, vendor compliance and quality agreementsSupport batch release, product quality reviews, complaints,



recalls and quality investigationsMaintain regulatory dossiers, submission records and product-specific regulatory documentationSupport ARTG applications and preparation of regulatory submission documentationReview product labels, artwork and packaging for regulatory complianceSupport product lifecycle activities including registrations, variations, renewals and regulatory approvalsSkills and ExperienceTertiary qualification in Pharmacy, Pharmaceutical Sciences, Life Sciences, Biotechnology, Chemistry, Microbiology or a related disciplineExperience within pharmaceutical Quality Assurance, Regulatory Affairs or a related environmentUnderstanding of GMP requirements and pharmaceutical quality systemsExposure to QMS processes such as deviations, CAPAs, change controls or complaints would be highly regardedKnowledge or exposure to TGA regulatory requirements would be advantageousExperience within a pharmaceutical sponsor, manufacturer or distribution environment would be beneficialStrong attention to detail and documentation skillsExcellent organisation and time management skills with the ability to manage competing prioritiesStrong communication and stakeholder management skillsAbility to work independently while contributing effectively within a cross-functional teamCultureJoin a collaborative and quality-focused environment 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