Quality Assurance Associate - ANZ

Clinigen; Sydney; On-site; AUD 120,000 - 160,000; Full time

Job summary

Clinigen is seeking a Quality Assurance professional to lead QA functions for the Link ANZ warehouse facilities, ensuring GDP, GMP, ISO and local regulatory compliance across the site.

The role covers product release, complaint handling, investigations, CAPAs, quality metrics, training, audits, vendor management and risk management for ANZ operations. Collaboration with internal stakeholders is essential to drive continuous improvement and timely compliant product release.

Responsibilities

• Review and approve product release for distribution in accordance with GDP requirements and regulatory standards.
• Coordinate investigations with internal stakeholders, customers and manufacturers as required.
• Identify and implement corrective and preventive actions where appropriate.
• Prepare monthly quality reports and performance metrics for the ANZ business.
• Review and approve returned product assessments in accordance with GDP requirements.
• Investigate temperature excursions affecting medicinal products and assess impact.
• Support Quality Manager with risk management and escalation of issues.
• Gather data to support investigations and root-cause analysis of nonconformances.
• Drive training delivery on GDP, GMP, SOPs, and compliance procedures.
• Plan and participate in internal and external audits and manage audit findings and CAPAs.
• Maintain approved supplier lists and vendor oversight as part of QA duties.
• Organise and communicate quality information to stakeholders and ensure documentation is up to date.
• Ensure GDP compliance and alignment with regulatory guidelines across the site.

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 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

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 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.