Quality Assurance & Compliance Associate Full-time Sobi Location: Australia Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them.
Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.
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:
Quality Assurance 60%
Oversee the Sobi QMS in Australia, including training rollout, annual reviews and ad hoc updates, on a timely basis; Collaborate with Supply Chain to ensure the required quality standards are met; Review records and change requests to ensure completeness, consistency, relevance and clarity; Review and approve GxP documents, so that 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; Compliance 40%
Be an internal advocate for compliance: communicate requirements, train & support staff on a need basis; Manage the transfer of value (ToV) data and reporting for Sobi Australia; Coordinate Email / Consent capture according to privacy laws, and consolidate into the company CRM (Veeva); Conduct regular compliance monitoring (contract, event organisation, etc.)
to ensure audit readiness.
Key Responsibilities:
Quality Assurance 60%
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; Compliance 40%
ToV data and reporting Management of Contracts/agreements Management of Consent / Email data collection Compliance monitoring 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.
Minimum Requirements:
Relevant qualification in Quality Assurance and or Compliance.
5+ years' experience in quality systems management within a pharmaceutical industry environment.
Familiarity with Regulatory Standards (TGA (PIC/S), FDA (CFR), and ISO-9001), Quality Risk Management, Quality Control, and Quality Assurance systems.
Experience in communicating complex information, including technical writing, analysis, and accuracy.
You will have excellent analytical, problem solving, organisational and communication skills.
Ability to function autonomously, be proactive and adapt to constantly changing business demands.
Capacity to recognise a critical matter and escalate to appropriate stakeholders where required.
Proficient IT skills in all business-related packages including MS Office, Veeva, SalesForce.
All your information will be kept confidential according to EEO guidelines.
The role is based in Sydney – office-hybrid, reporting to the Finance and Operation Manager.
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