Quality Assurance Manager
3 weeks ago
As the Quality Assurance Manager, you will play a key role in the overall management of the Quality Management System (QMS). This is a fantastic opportunity to utilize your expertise in a dynamic and growing organization. You will be responsible for leading all quality assurance initiatives, designing and implementing the QMS, and ensuring compliance with regulatory requirements.
Key Responsibilities:
- Lead all quality assurance initiatives to ensure compliance with regulatory requirements
- Design and implement the Quality Management System (QMS) to meet industry best practices and regulatory requirements
- Oversee audit schedules and the execution of audit plans, reviews, and audit reports
- Track corrective and preventive actions associated with vendors in accordance with applicable regulations and guidelines
- Work closely with Production, Regulatory Affairs, and other departments to ensure compliance with QA/RA requirements
Requirements:
- 3-5 years of experience in a leading Quality position within pharmaceuticals, radiopharmaceuticals, nuclear medicine, and/or sterile injectables
- Tertiary qualification in Radiopharmaceuticals, Nuclear Medicine, or equivalent
- Demonstrated experience designing, implementing, and monitoring a QMS to meet regulatory requirements
- Excellent written and verbal communication skills with previous experience in technical writing for SOPs, manuals, and other quality documentation
- A proactive and adaptable approach to evolving product requirements
This is a fantastic opportunity to take on a lead role and contribute to the growth and success of the organization. If you are a motivated and experienced Quality Assurance professional looking for a new challenge, please apply.
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Richlands, Queensland, Australia Fuse Recruitment Full time{"title": "Quality Assurance Manager", "subtitle": "Lead Quality Assurance Role in Clinical Stage Radiopharmaceutical Company", "bulletPoints": ["Lead all quality assurance initiatives supporting the manufacture of radiopharmaceutical APIs.", "Design, monitor, effectively implement, maintain and update the Quality Management System (QMS) to ensure...
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