See SEEK advertisement here Location: Keilor Park, Victoria Competitive remuneration package plus superannuation Social events Career development opportunities Full-time Position About the company This business is a leading radiopharmaceutical company with a strong presence in both Australian and global markets. We manufacture and supply high-quality products and radiopharmaceuticals supporting Nuclear Medicine, Oncology, and specialised contract manufacturing services. We play a key role in advancing patient care and medical diagnostics. Culture You’ll join a collaborative and values-driven team based at the Melbourne Pharmacy. The culture is open, respectful, and focused on continuous improvement, where ideas are welcomed and quality is everyone’s responsibility. Team members are supported to grow, speak up, and contribute meaningfully to how the business operates. Your new role Reporting to the National Pharmacy Quality Manager, you will oversee and ensure the quality systems (QMS), quality assurance (QA), quality control (QC), validation and microbiology activities conducted at the Melbourne Pharmacy site, and provide support when necessary to other sites and business units. The role supports Pharmacy Operations, Theranostics and Clinical Trial CDMO activities, ensuring compliance with regulatory requirements, GMP principles, and GMS quality standards. What you will get in return A supportive, family-oriented work environment Opportunities for professional growth and career development Team building activities and social connection A birthday day off to celebrate you Key Responsibilities Oversee all quality-related activities at the Melbourne Pharmacy site, ensuring compliance with PE.010, GMP and GMS quality standards. Lead the development of a strong quality culture by setting expectations, positively influencing behaviours, and driving consistent adherence to quality and compliance standards across the site. Management of site quality records including but not limited to Controlled documentation, deviation, change control, training, customer complaint and preventive and corrective action records. Assist with the performance of Periodic Quality Reviews (PQRs) and Site Management Reviews (SMRs) to assess and enhance quality performance. Report to the National Pharmacy Quality Manager regarding any quality concerns, non-compliance issues, or significant findings that require attention. Generating quality performance metrics for site and present to National Pharmacy Quality Manager. Collaborate with suppliers to ensure adherence to quality standards, while conducting audits as per supplier management process as necessary to approve suppliers. Conduct risk assessments related to product quality and develop mitigation strategies to minimise potential issues. Manage the site training matrix and compliance to training programmes. Manage all site validation activities under the advice of the National Validation Manager. Assist with performance of recalls and ensure that root cause analysis is performed and corrective actions implemented. Assist with internal audits to ensure adherence to quality standards and implement opportunities for improvement. Conduct investigation for any quality incidents and develop action plans for resolution. Participate in regulatory audits as an auditee, ensuring preparedness and compliance. Develop and implement training programs for staff on quality-related topics and best practices at the site and across the organisation. Oversee the quality control function, including inspection and testing of raw materials, in-process components, and finished products. Manage environmental monitoring and related microbial testing to ensure compliance with microbiological standards. Ensure that QC and microbiological testing activities are carried out effectively, trends reported and any out of specifications are investigated accordingly. Collaborate with validation team to plan and review validation activities. Monitor quality metrics and trends, providing analysis and recommendations for continuous improvement. What you will need to succeed Bachelor’s degree in Pharmacy, Life Sciences, or a related field. 1 year experience in quality-related field within GMP manufacturing or pharmacy compounding facilities or any related field within quality. Good understanding of quality assurance principles, regulatory requirements, and its applicability within a manufacturing environment. Able to understand the Change Management principles. Good analytical skills and attention to detail. Exhibits good self-leadership skills. Strong communication and interpersonal skills, with the ability to work collaboratively across teams.
