Quality Assurance Specialist
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This is a challenging role requiring the management and maintenance of our Quality Management System. The successful candidate will be responsible for ensuring the QMS is fit for purpose and making necessary changes.
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The key responsibilities include managing communications with regulatory authorities, providing QA expertise to support operations, and preparing written responses to inspections. Additionally, the role involves reviewing and approving quality documents, ensuring compliance with regulatory requirements, and identifying opportunities for continuous improvement.
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The ideal candidate will have a thorough understanding of Good Manufacturing Practice (GMP) and regulatory expectations for medicinal products and medical devices. A minimum of 5 years of experience in Quality Assurance within the healthcare industry is required, along with strong communication and organizational skills.
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A bachelor's degree in science or equivalent is essential, and a trained auditor certification would be an advantage. The ability to work independently and as part of a team, analyze complex problems, and identify solutions is crucial for this role.
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This position requires strong interpersonal and influencing skills to build relationships internally and externally. Regular travel may be required to fulfill the role.
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Bonus: Our company is committed to equal employment opportunity and complies with equal employment opportunity laws.
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