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Form of workSteritech is the leading supplier of contract Sterilization, Decontamination and Phytosanitary services in Australia with operations in Victoria, New South Wales and Queensland. Steritech provides Irradiation and ETO Gas processing services to the Medical Device, Agricultural, Pharmaceutical, Australian Biosecurity and General Industries.
We are a customer focused, proactive company that provides clients with unique opportunities to open their business to new markets through innovative, technically advanced solutions. We are looking for a mature, highly motivated, and organized team player to join us as the Quality Officer in our Merrifield office to support the quality department in maintaining regulatory compliance.
This is a Fulltime Permanent Position
Reporting to the General Manager and Group QA/RA Manager your key responsibilities will include.
• Establishing, maintaining validity, and ensuring content relevancy of all ‘right to process’ manufacturing / Operations Licenses, certifications and registrations pertaining to Industrial X-Ray and Electron Beam accelerator process.
• Upholding the site QMS to the relevant quality standards and industry specific guidelines by tailoring our processes accordingly and ensuring ongoing compliance to all relevant legislation governing the X-Ray and Electron Beam accelerator operations.
• Planning, coordinating and leading quality system audits / inspections of internal, external and regulatory nature and collaboratively formulating responses to deficiencies raised whilst upholding the commitment for implementation of all defined and approved corrective actions.
• Defining, establishing, implementing and maintaining in-process controls for the X-Ray and Electron Beam accelerator system by leading all site procedural updates in a quality-controlled manner and facilitating departmental collaborative review and approvals of said documents.
• Establishing training regimes (including, but not limited to, initial and routine re-fresher trainings), verifying competency of site employees by facilitating and supervising onsite training tasks and promoting off site / external training activities, all whilst maintaining the accuracy and integrity of all quality system training records and certificates pertaining to X-Ray and Electron Beam accelerator systems.
• Evaluating and liaising with critical and non-critical suppliers, ensuring that all services rendered and/or consumables purchased adhere to the required specifications prior to acceptance into the sites manufacturing environment.
To be considered for this fulltime permanent position, you must possess the following attributes and
Skills:
• Minimum 2-3 years working in a pharmaceutical or other highly regulated industry with a specialization in sterility and phytosanitary assurance.
• Sound understanding of Quality Management System requirements for ISO13485 and/or other highly regulated industry standard, including a working knowledge of GMP Manufacturing or industry equivalent, and able to apply such requirements.
• Sound understanding of Quality Management System requirements for Phytosanitary Irradiation programs at state, federal and international level to include USDA, Vietnam, Thailand and New Zealand.
• Sound understanding of Irradiation and Dosimetry standards to include at minimum ISO11137, ISO51649, ISO51261, ISO51707.
• Responsible and leadership focused attitude exuding drive and enthusiasm.
• Strong communication ability and confidence working with all levels of personnel, including but not limited to; employees, internal/ external stakeholders and regulatory bodies.
• Confident, self-assured, but ‘listening’ characteristic in dealing with customers and regulatory bodies.
• A Tertiary Qualification in Science or Engineering or related discipline and/or awareness of the general principles of sterilization, validation, and related microbiology.
To submit your application please do so by clicking the “Apply for this job” link and submitting your current resume and cover letter outlining how you meet the above criteria.
To apply for this position, you must have the legal right to live and work in Australia.
