About the company
An established, global pharmaceutical company with well-known products and an excellent reputation, based in North Sydney.
About the opportunity
This 12-month QA contract will provide support to the QA team with a 70% focus on product complaints and assist with local commercial release and distribution. You will liaise directly with the customers, healthcare professionals and cross functional teams to ensure all product complaints are accurately recorded and managed.
You will manage all Non-Medical complaints, for example, this may be damaged product packaging.
- Responsible for acting as a customer facing role for the overall management of Non-Medical Complaints for the Australian and New Zealand Market.
- Ensure all non-medical complaints are registered and liaise with manufacturing sites to ensure investigations are completed, reported and final customers letters are compiled and issued within established KPI's
- Ensure all follow-up activities with the customer is acted upon and recorded as per established SOP
- Coordinate the return of Non-Medical complaint samples for laboratory examination .
- Perform reconciliation for Non-Medical Complaints with local and 3rd party vendors.
- Perform monthly reports and trending for local management reviews
- Act as back-up for managing and registering non-medical complaints systems during period of leave coverage of QA staff within the APAC region.
- Develop and maintain APAC SOPs, related to Non-Medical Complaint handling, that follow local regulations and that are in accordance with corporate SOPs .
- Provide support on delivering GxP training for the local and regional teams including 3rd party suppliers
- Responsible for general QA filing and archiving documentation against established retention period and processes
- Contribute to implementation of corrective and preventative actions for all incidences of non-compliance.
- Assist in product release process for the Australia and New Zealand Market, includes reviewing certificates of analysis to ensure compliance to marketing authorization is maintained. Includes product temperature evaluation and assessment for product to be released for distribution.
- Assist in quality assessment of returned product process for the Australia and New Zealand Market and the administration control of product status within SAP management system.
Skills and Experience
- Tertiary qualification in Science, Engineering, or relevant discipline
- 2 + years' experience in a QA (Quality Assurance) role within Pharma or Devices industry
- Experience working in a commercial QA role in Australia, is preferred.
- Good understanding of and experience working with, the TGA's cGMP or similar quality management systems
- Experience with SAP and Trackwise (or similar) strongly preferred
- Intermediate skills in Microsoft Word and Excel with strong database management experience
- Requires very high attention to detail and accuracy
- Excellent communication, verbal and written
How to Apply
Click apply to submit your resume or if you would like more information about the role contact Joanna Murphy, Senior Recruitment Consultant on +61 2 8877 8718 for a confidential discussion. Please note - HPG offices are currently closed and will re-open on Mon Jan 4th. All applications for this role will be reviewed then.
( SK927795A )