The Opportunity

We are looking for a Production Support Coordinator to join our team at our Parkville site. Reporting to the Production Support Team Leader, you will provide compliance support to manufacturing staff and processes within each functional area to produce required product or service in accordance with cGMP and Seqirus Quality Management System. The role is responsible for the management of deviation, CAPA investigation, and monitoring continuous compliance with cGMP, TGA, FDA, OGTR, DAFF requirements and EHS regulations.

This is a full-time fixed term role until 31 October 2025 and will suit someone who has a strong understanding of cGMP and has experience working in a production environment.

The Role

• Support manufacturing to ensure that the product or service is manufactured or delivered in accordance with cGMP and Seqirus Quality Management System.
• Managing the Deviations system and assist production areas with investigations and facilitate the close out of all deviations within the required timelines.
• Managing the CAPA system for each deviation and assist production areas with CAPAs and facilitate the close out of all actions in accordance with agreed timelines.
• Prepare and facilitate change controls to be presented at Change Panel, where required.
• Attend meetings and assist in the performance of risk assessments as required to support manufacturing Seqirus business
• Support the operational area proactively to prevent deviations/out of specifications.

• Tertiary qualification in a related scientific discipline or on the job experience.
• Experience in a Pharmaceutical or manufacturing environment.
• Strong technical understanding of pharmaceutical manufacturing processes.
• Knowledge of cGMP/FDA/TGA/OGTR/DAFF regulations.
• Knowledge of Quality Management Systems, Seqirus business applications including SAP, TrackWise, Veeva, EDMS, SuccessFactors LMS and GLIMS.