Purpose of Role
- Develop and maintain the highest standards of quality and compliance to support Sobi’s practices in Australia.
- Implement systems and processes to ensure that Sobi products in Australia consistently meet or exceed established quality standards.
- Lead activities related to Good Manufacturing Practices (GMP), Quality Management Systems (QMS), and adherence to regulatory requirements.
- Ensure compliance with Industry Code of Conduct and company guidelines.
Job Description:
- Oversee, manage and update the Sobi QMS in Australia, including training rollout, annual reviews and ad hoc updates as required, and on a timely basis.
- Collaborate closely with Supply Chain to ensure the required quality standards are met; Review records and change requests on completeness, consistency, relevance and clarity;
- Review and approve GxP documents, ensuring all processes follow GxP;
- Prepare batch release documentation;
- Approve QA-controlled documentation (such as SOPs, batch records, working instructions);
- Conduct regular self-inspection activities to ensure audit readiness
- Support the development of Corrective and Preventative Actions (CAPAs) and continuous improvement activities;
- The role is based in Sydney – office-hybrid, reporting to the Finance and Operation Manager.
Key Responsibilities:
- Provide leadership in all matters relevant to the QMS (continuous improvement, training, etc.);
- Develop and manage company policies and Standard Operating Procedures (SOP) required by the QMS;
- QTC - Facilitate and assign related training to the affiliate employees;
- Sign relevant document after review of importation and repacking documents;
- Conduct root cause analyses, identify CAPAs, and determine product disposition to maintain the quality standards;
- Log non-conformance, change control and CAPAs into the QMS system;
- Assign to relevant stakeholder, follow up actions and closure;
- Support internal/external audits;
- Lead recall actions;
- Other projects, tasks and responsibilities as assigned by management;
- Behave ethically, responsibly, and professionally in accordance with Sobi’s values, internal policies and Australian Medicines Code of Conduct.
