Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Purpose:

Assist the Quality Assurance Manager in the overall development, maintenance, and continuous improvement of the Quality Management Systems at PCI Melbourne. Specifically, the compliance, management, training, implementation and updates of the PQS and e-PQS, and other GMP software systems requiring quality oversight (including but not limited to MasterControl and BlueMountain).

Maintain robust Quality monitoring (and the review of compliance to metrics) to ensure the assessment of an effective quality management system and the escalation of adverse trends.

Primary responsibilities:

- Oversee the overall management of the e-PQS (MasterControl), to ensure day-to-day operational and compliance requirements are met, compliance to regulatory requirements, and local and Corporate PCI procedures. This includes improvements/upgrades and local administrative functions.

- Provide quality oversight of site PCI PQS, and support improvements/upgrades of other GMP software systems as required (i.e. BlueMountain)

- Manage day-to-day review, approval and routing of GMP software system records (i.e. Mastercontrol, BlueMountain etc).

- Manage PQS training to new and existing employees, in the e-PQS (including but not limited to), deviations, customer complaints and CAPA

- Manage the review, approval and escalation of events, deviations and customer complaints.

- Support the completion of investigations to determine root cause and effective corrective and preventative actions to prevent recurrence

- Manage and drive continuous improvements to assist in enhancements in departmental operational performance, compliance to regulatory requirements, improvements in site Standard Operating Procedures (SOPs) and meeting external and internal customer requirements, with respect to quality, service, and lead time.