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 escalate 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 escalate 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…