Job Title: Quality Assurance Engineer
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We are seeking a skilled Quality Assurance Engineer to join our team. The successful candidate will be responsible for ensuring the quality of our products and services.
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About the Role:
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In this role, you will be responsible for ensuring that all computerized systems are qualified in compliance with Data Integrity policies and regulatory requirements. You will also coordinate, direct, and actively participate in the validation of site equipment, facilities, utilities, processes, and software in accordance with company policies, FDA, European cGMP, and GAMP standards.
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Responsibilities:
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* Ensure all computerized systems are qualified in compliance with Data Integrity policies and regulatory requirements.
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* Coordinate, direct, and actively participate in the validation of site equipment, facilities, utilities, processes, and software in accordance with company policies, FDA, European cGMP, and GAMP standards.
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* Generate and maintain Validation Master Plans.
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* Develop and oversee Project Validation Plans.
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* Create validation plans, protocols, and final reports adhering to cGMP standards.
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* Review and approve all validation protocols and final reports.
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* Manage validation change control processes.
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Requirements:
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To be successful in this role, you will need:
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* A third-level qualification in a relevant engineering or scientific discipline.
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* Minimum of 5-10 years' experience in a cGMP-regulated environment.
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* A good understanding of regulatory requirements.
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* High attention to detail and concentration to ensure accuracy and compliance.
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* Proven problem-solving skills and adaptability to new regulatory requirements.
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* Innovative thinking with the ability to propose, demonstrate, and implement new solutions regularly.
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