Quality Assurance & Control (Science & Technology)
At Specialty Probiotics Australia (SPA), we are driven by a vision to make the transformative power of probiotics accessible to everyone. As leaders in probiotic innovation, we are dedicated to delivering high-quality solutions that elevate health and wellbeing. Our mission is to simplify the complexities of probiotic manufacturing, offering superior products that enable brands to thrive in a competitive and evolving market.
With decades of combined experience, we have an expert team of scientists, nutritionists and innovators which has allowed us to gain access to a global team of probiotic specialists. We are united in being passionate about revolutionizing the future of probiotics. We tackle the challenges that have historically hindered growth in the industry, pushing the boundaries of development and manufacturing to create breakthrough solutions. At SPA, we are committed to enhancing lives through innovation, science, and a relentless focus on quality.
Tasks and Responsibilities
Develop, implement, and maintain a robust Quality Management System that complies with both TGA regulations and GMP standards. Build on the existing Quality structure and documents and add or improve where necessary. Design and conduct GMP-focused training programs for key personnel and managers, implementing training programs for production and other departments to ensure they adhere to quality and safety standards. Lead the organization through TGA certification processes, ensuring audit readiness and seamless compliance with all regulatory and quality standards. Conduct internal audits and reviews to assess and enhance GMP compliance within all operational aspects. Lead Quality Management Review meetings. Implement supplier quality management programs in line with PIC/S requirements, conducting audits and assessments to ensure supplier compliance. Address and resolve customer quality complaints, adhering to GMP and TGA standards. Work in collaboration with the Supply Chain, R&D and Production teams to prepare raw material specifications, finished product specifications, and batch manufacturing/packaging instructions. Take a leadership role in Quality Risk Management and ensure risk assessment tools are used across the QMS, making decisions on a risk-based approach where necessary. Manage deviations, non-conformances, change controls, and drive continuous improvement by implementing corrective actions and preventive measures. Ensure that all GMP documents are prepared, reviewed, approved, updated, and archived in accordance with document control requirements. Maintain GMP records and results as per Data Integrity requirements. Lead Equipment Qualification, Cleaning Validation, Process Validation, Analytical Method Validation/Revalidation. Offer expert advice and support on GMP and TGA compliance to internal teams and external partners and facilitate compliance projects. Communicate with subcontractors, raw material suppliers, packaging suppliers, customers, and local/overseas regulatory authorities to enable delivery of the company strategic objectives and goals. Minimum Requirements/Qualifications
Tertiary degree in a relevant scientific, pharmaceutical, or engineering background. Additional qualifications or certifications in quality management systems, regulatory affairs, or a related discipline are highly desirable. A minimum of 8 years of experience within the pharmaceutical or biopharmaceutical industry including at least 2 years of experience in senior quality management positions. Previous experience in implementing, managing, and enhancing Quality standards in accordance with TGA guidelines and PIC/S requirements. Capable of independently leading Qualification and Validation activities. Demonstrate competency in statistical methods, data analysis, and quality control processes that are critical for ensuring product quality and safety. Candidates with experience and knowledge in both APIs and Finished Products Manufacturing will be highly desirable. Advanced computer skills in Microsoft Office Excel and Suite, and other tools relevant to quality documentation and record-keeping. How to Apply:
Apply with a cover letter addressing each point of the Minimum Requirements/Qualifications section.
Your application will include the following questions:
Which of the following statements best describes your right to work in Australia? How many years' experience do you have as a Quality Assurance Manager? Have you worked in a role which requires a sound understanding of Good Manufacturing Practices (GMP)? How many years' experience do you have in a quality control (QC) role? How many years of auditing experience do you have? #J-18808-Ljbffr