Quality Assurance Associate

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases.

You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.

Requirements

in Europe.

Actively participating in and supporting the quality needs of the commercial programs across the organisation’s country jurisdictions especially the expansion of the MAH, secondary packaging & distribution operations. Provide support to other TLX programs and other team members as required. The role is located in Telix Innovations, Herstal (Belgium) with the role reporting to the local Senior Quality Assurance manager.

Key Accountabilities: Understand and adhere to GMP Policies. Prepare, review and approve documents within Telix Quality Management System (QMS) and eQMS, Master Control.

, quality system registers and training on Telix QMS. Participate in writing, implementing and approving Deviations, Investigations, CAPA Change Control and complaint reports. Participate in the management and completion of internal quality audits on all Telix systems within the QMS, prepare reports and recommend solutions and close out activities under the guidance of the Senior Quality Assurance Manager.

Participate in the management of supplier quality audits, vendor assurance activities and supplier quality agreements.

. Collaborate with production/manufacturing teams to monitor all work according to

under Telix quality system.

Participate in batch release activities for Telix in the QMS for commercial and clinical products (as required). Provide support to cross-functional team. Identify required system and process gaps within the Telix QMS and facilitate corrective and preventative actions as required.

Personal development – maintain standard knowledge and make recommendations for professional development and training. Education and Experience: Bachelor’s degree required. Orientation in pharmacy, biochemistry or science field is highly preferred.

2+ years of experience in quality position from a regulated industry. Knowledge of applicable regulations within EU and the USA.

Previous experience writing and reviewing with understanding SOPs and specifications. Languages: English and French fluency.