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 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.

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