Major Tasks & Activities:Product Release for DistributionReview and approve product release for distribution in accordance with applicable GDP requirements, company procedures and regulatory requirements.Verify that all release requirements have been met prior to product distribution.Identify, assess and elevate actual or potential non-conformances that may impact product quality, compliance or release status.Ensure all release decisions are documented and supported by appropriate records.Liaise with internal stakeholders to resolve issues that may impact timely product release.Customer ApprovalsReview and approve customer applications, as requiredEnsure all documentation is saved and filed appropriatelyReview and reapproved customers, as per the defined re-evaluation periodComplaint ManagementManage the receipt, review, investigation and closure of customer complaints.Coordinate investigations with internal stakeholders, customers and product manufacturers as required.Identify and implement corrective and preventive actions where appropriate.Analyse complaint trends and escalate significant quality issues to management.Reporting and Quality MetricsPrepare monthly quality reports and quality performance metrics for the ANZ business.Analyse and trend quality system data, including complaints, temperature excursions, returns and other quality indicators.Prepare presentations and reports for management review meetings and other stakeholder forums.Present quality data and trends to management and relevant stakeholders, highlighting risks and improvement opportunities.Returns ManagementReview and approve returned product assessments in accordance with GDP requirements and company procedures.Determine disposition of returned goods based on available quality information and supporting documentation.Ensure returned product investigations and decisions are appropriately documented.Identify and elevate quality or compliance concerns arising from returned goods.Temperature Excursion ManagementReview, investigate and assess temperature excursions affecting medicinal products.Perform quality risk assessments to determine product impact and disposition.Liaise with customers, logistics providers,



manufacturers and internal stakeholders to obtain information required for assessment.Ensure excursion investigations are completed and documented within required timelines.Trend temperature excursion data and identify opportunities for continuous improvement.Quality Risk ManagementApply and continue to develop an understanding of Quality Risk principles, with respect to Premises, Equipment, Computerised Systems, Processes, Qualification, and TransportationSupport Quality Manager with the communication and review of risks to the quality of medicinal products.Investigation and Reporting Nonconformances/Implementation of Corrective and Preventative ActionsGather information and data to support the investigation all deviations and record root cause, impact assessment and trend analysisSupport the Identification of corrective and preventive actions, as well as system improvementsFacilitate the implementation of corrective actions in a compliant and timely mannerTraining ActivitiesManage and maintain the training matrix and reviewal of training records.Drive the delivery of training to relevant company employees in the Code of GDP, GMP, SOP's and other necessary proceduresParticipate in internal & external training as required, to ensure Quality Assurance practices are up to date and compliant with best practice and legislation requirementsManage and support internal compliance inspectionsInspectionAuthorise release of incoming stock after determination of complianceInspection and processing of returned goodsMaintain and review complaints databaseLog all entries and process responses, coordinating with Med Info and Customer Service if requiredWork with the customer services team to investigate customer complaints & stock returnsSegregation and reconciliation of rejected stockAuditingOrganise and participate in Internal Audits, as per a defined scheduleSupport Quality Manager with writing audit reports and manage findings and audit related CAPAsSupport and participate in External AuditsMaintain accurate records and appropriate documentation of any audits relevant to QASupport the implementation of any necessary actions as a result of a conducted auditMaintain a current Approved Supplier List (ASL)Support the necessary business functions in the setup of new VendorsReview documentation provided, and approve Vendors as requiredIdentify Vendors that require reapproval, defined by their risk to the business,



and arrange for reapprovalAdministrationPlan and undertake special projects and investigations as defined by the companySupport Quality Manager with any new global initiatives and projects.Ensure filing and documentation is up-to-date and is compliant with standard processes and formatsComplete required reports within designated timeframesOrganise, support, and participate in meetings as neededLiaise with the Quality Assurance Manager and internal stakeholders as required to ensure projects are conducted efficientlyMaster computer skills and required software programsEnsure all GDP requirements are within governmental regulation guidelinesStakeholder ManagementBuild and maintain effective relationships with customers, suppliers, logistics providers and internal stakeholders.Provide quality guidance and support to business functions on quality and compliance requirements.Represent the Quality function in cross-functional meetings, projects and initiatives.Collaborate with stakeholders to resolve quality issues and drive continuous improvement activities.Knowledge and ComplianceAssist in identifying and solving compliance issues within the CompanyMaintain high standards of cleanliness, tidiness and organization of work areasAttend relevant industry conferences to expand knowledge of relevant therapeutic areasPromptly notify Link's pharmacovigilance unit of all adverse reactions reported on Link's productsMaintain up-to-date knowledge of Link standard operating procedures and policies and ensure compliance at all timesCarry out your duties in adherence to GDP regulationsContributes to a Quality-focused mindset; Quality is everyone's responsibility.Ensure every team member has the opportunity to work in a safe and healthy work setting.Ensure your Company related activities comply with relevant Acts, legal demands and ethical standardsTertiary qualifications in a technical discipline or relevant experienceDemonstrated experience in an operations roles within the pharmaceutical and allied industryExperience of working within a GDP and GMP Quality Management Systems, an understanding of facility design and operations.Demonstrated ability to build cross-functional relationshipsComfortable working autonomously (and in teams) with the ability to adapt to changing priorities.Be careful - Don't provide your bank or credit card details when applying for jobs.
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📌 Quality Assurance Associate - Anz (Sydney)
🏢 Clinigen Group
📍 Sydney