Quality Assurance Specialist
1 week ago
About Sharp & Carter
A leading provider of high-quality sterilization services, Sharp & Carter is dedicated to maintaining the highest standards in safety and quality while ensuring compliance with regulatory requirements and industry standards. With a strong commitment to innovation, excellence, and rigorous regulatory standards, the company prioritizes a clean, controlled environment essential for product integrity and superior results.
The Role
As a Quality Assurance Officer, you will be responsible for ensuring that all aspects of the company's quality management system are consistently implemented, aligning with regulatory requirements and industry standards. This includes maintaining compliance with relevant legislation, documenting company procedures, and keeping accurate records of quality assurance, quality control, and operational activities. You will also assist in identifying and resolving quality issues, monitor inventory of critical consumables, and verify incoming goods.
Key Responsibilities
- Ensure compliance with TGA regulations and industry standards.
- Develop and maintain quality management systems.
- Conduct quality checks on customer products.
- Manage equipment calibration and maintenance programs.
- Participate in internal, external, and regulatory audits.
Requirements
- Tertiary qualification in Science or related discipline.
- Awareness of general principles of sterilization, validation, and microbiology.
- Minimum 2-3 years' experience in a quality function within a manufacturing, pharmaceutical, or healthcare environment.
- Knowledge and experience with Quality Management Systems (ISO9001, ISO13485) and TGA Audits.
- Strong analytical, problem-solving, and decision-making skills.
- Excellent communication and collaboration skills.
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