Job Description
Within this role, you will drive and support the delivery of operational excellence and implementation of all Quality Assurance functions for the Link ANZ warehouse facilities, ensuring these functions are performed in compliance with company policies, ISO, GDP and GMP requirements and as required by local issuing authorities.
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 escape 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 escape 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 escape 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 ReportingNonconformances/Implementationof 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
Vendor Management
Maintain a current Approved Supplier List (ASL)




Support the necessary business functions in the setup of new 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 current global initiatives and projects.
Ensure filing and documentation is up-to-date and is compliant with standard processes and formats
Complete required reports within designated timeframes
Organise, support, and participate in meetings as needed
Liaise with the Quality Assurance Manager and internal stakeholders as required to ensure projects are conducted efficiently
Master computer skills and required software programs
Ensure all GDP requirements are within governmental regulation guidelines
Stakeholder Management
Build 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 Compliance
Assist in identifying and solving compliance issues within the Company
Maintain high standards of cleanliness, tidiness and organization of work areas
Attend relevant industry conferences to expand knowledge of relevant therapeutic areas
Promptly notify Link's pharmacovigilance unit of all adverse reactions reported on Link's products
Maintain up-to-date knowledge of Link standard operating procedures and policies and ensure compliance at all times
Carry out your duties in adherence to GDP regulations
Contributes 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 environment.
Ensure your Company related activities comply with relevant Acts, legal demands and ethical standards
Tertiary qualifications in a technical discipline or relevant experience
Demonstrated experience in an operations roles within the pharmaceutical and allied industry
Experience of working within a GDP and GMP Quality Management Systems, an understanding of facility design and operations.
Demonstrated ability to build cross-functional relationships
Comfortable working autonomously (and in teams) with the ability to adapt to changing priorities.

📌 Quality Assurance Associate - Anz (New South Wales)
🏢 Clinigen
📍 New South Wales