
Quality Assurance and Validation Specialist
3 days ago
We are seeking a skilled Quality Assurance and Validation professional to join our team, working on medical devices in a dynamic and innovative environment. The ideal candidate has 3+ years of experience in validation/quality assurance, with a strong background in GMP regulations and knowledge of quality systems.
Key Responsibilities:- Validate site equipment, utilities, processes, and software in compliance with policies, FDA, European cGMP, and GAMP standards.
- Develop and implement Site Validation Master Plans, Project Validation Plans, and schedules.
- Generate validation protocols and final reports to cGMP standards.
- Manage validation, exception event, and change control processes.
- Maintain the overall cGMP compliance of production areas.
- 3+ years of experience in validation/quality assurance in medical device plastics processing, moulding or assembly operations.
- Knowledge of cGMP and regulatory requirements relating to the medical device industry.
- Degree in engineering or scientific discipline.
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Validation Assurance Specialist
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Manufacturing Quality Assurance Specialist
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Quality Assurance Specialist
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Quality Assurance Specialist
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Quality Assurance Specialist
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Galway, Galway, Ireland beBeeQuality Full time €60,000 - €80,000Job Title: Quality Assurance SpecialistWe are seeking a highly experienced and skilled Quality Assurance Specialist to play a key role in ensuring product quality during early development phases through to commercial.About the Role:Lead compliance and improvement activities associated with the quality system (e.g. CAPA, audit programs, personnel...
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