Quality Assurance Specialist

4 weeks ago

Sydney, New South Wales, Australia Sobi Full time
Job Description

Sobi is seeking a highly skilled Quality Assurance professional to join our team in Sydney. As a Quality Assurance Specialist, you will be responsible for ensuring the highest standards of quality and compliance in our Australian operations.

Key Responsibilities
  • Develop and maintain quality systems and processes to ensure compliance with regulatory requirements.
  • Lead activities related to Good Manufacturing Practices (GMP), Quality Management Systems (QMS), and adherence to industry standards.
  • Collaborate with Supply Chain to ensure quality standards are met and review records and change requests for completeness, consistency, relevance, and clarity.
  • Review and approve GxP documents and prepare batch release documentation.
  • Approve QA-controlled documentation, conduct regular self-inspection activities, and support the development of Corrective and Preventative Actions (CAPAs).
  • Provide leadership in all matters relevant to the QMS and develop and manage company policies and Standard Operating Procedures (SOPs).
Requirements
  • Relevant qualification in Quality Assurance.
  • 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.
  • Excellent analytical, problem-solving, organisational, and communication skills.
  • Ability to function autonomously, be proactive, and adapt to constantly changing business demands.
  • Capacity to recognise critical matters and escalate to appropriate stakeholders.
  • Proficient IT skills in all business-related packages, including MS Office, Veeva, and SalesForce.
  • Proficient in English.
  • Valid / Unrestricted Australian driver's licence.

Sobi is an equal opportunities employer and welcomes applications from diverse candidates. All applications will be treated confidentially according to EEO guidelines.

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