Major Tasks & Activities:

Product Release for Distribution

Review 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 Approvals

Review and approve customer applications, as required Ensure all documentation is saved and filed appropriately Review and reapproved customers, as per the defined re-evaluation period Complaint Management

Manage 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 Metrics

Prepare 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 Management

Review 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 Management

Review, 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 Management

Apply and continue to develop an understanding of Quality Risk principles, with respect to Premises, Equipment, Computerised Systems, Processes, Qualification, and Transportation Support Quality Manager with the communication and review of risks to the quality of medicinal products. Investigation and Reporting Nonconformances/Implementation of Corrective and Preventative Actions

Gather information and data to support the investigation all deviations and record root cause, impact assessment and trend analysis Support the Identification of corrective and preventive actions,



as well as system improvements Facilitate the implementation of corrective actions in a compliant and timely manner Training Activities

Manage 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 procedures Participate in internal & external training as required, to ensure Quality Assurance practices are up to date and compliant with best practice and legislation requirements Manage and support internal compliance inspections Inspection

Authorise release of incoming stock after determination of compliance Inspection and processing of returned goods Maintain and review complaints database Log all entries and process responses, coordinating with Med Info and Customer Service if required Work with the customer services team to investigate customer complaints & stock returns Segregation and reconciliation of rejected stock Auditing

Organise and participate in Internal Audits, as per a defined schedule Support Quality Manager with writing audit reports and manage findings and audit related CAPAs Support and participate in External Audits Maintain accurate records and appropriate documentation of any audits relevant to QA Support the implementation of any necessary actions as a result of a conducted audit Maintain a current Approved Supplier List (ASL) Support the necessary business functions in the setup of current Vendors Review documentation provided, and approve Vendors as required Identify Vendors that require reapproval, defined by their risk to the business, and arrange for reapproval Administration

Plan and undertake special projects and investigations as defined by the company Support Quality Manager with any new g

📌 Quality Assurance Associate (Sydney)
🏢 Clinigen Group
📍 Sydney