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Validation & Compliance Specialist
Published on: Oct 18, 2024 Country: United Kingdom Location: Dartford Job Category: Quality Employment type: Regular Full Time Summary
In this role you will oversee and coordinate the Site Validation Programme. This will involve: leading and coordinating the Site Validation Review Board, overseeing the implementation of the S-VMP and managing and supporting Validation activities for new and existing Site validations. Responsibilities:
Oversee and coordinate the site Validation Programme. Lead and coordinate the site Validation Review Board, overseeing the implementation of the S-VMP. Manage and support Validation activities for new and existing site validations including: Process Validation: Develop, execute, and maintain validation protocols and reports for all manufacturing processes in accordance with ISO 13485 and IVDR regulations. Cleaning Validation: Establish and perform cleaning validation protocols and studies to ensure compliance with company and regulatory requirements, ensuring the cleanliness of manufacturing equipment and environments. Test Method Validation: Validate and verify analytical and testing methods to ensure they are suitable for their intended use, producing reliable and reproducible results. Spreadsheet Validation: Conduct validation of spreadsheets used for data handling and analysis to ensure accuracy and compliance with regulatory standards. Contribute to project Cross Functional Teams (CFTs) as a Validation subject matter expert, ensuring adherence to validation policies, procedures, safety, and training. As required, liaise with engineering and external vendors regarding equipment User Requirements Specifications (URS’s), Factory Acceptance Trials (FAT’s) and any other associated validation issues. Develop, execute, and maintain validation protocols, assigning tasks to site personnel as necessary. Review and approve validation documentation to ensure compliance with ISO 13485 and relevant regulatory standards. Responsible for managing site risk management plans and reports, ensuring compliance with regulatory standards and company policies. Actively participate in site projects, including technology transfers and new product development initiatives, ensuring that validation and compliance considerations are integrated from the onset. Prepare for and support internal and external audits, including regulatory inspections. Develop and roll out Validation training for the department and site. Liaise with and seek appropriate advice from the other DiaSorin plants worldwide. Approach the role in a flexible manner and be prepared to adapt to requirements outside of the immediate role that are essential to the organisation. Experience, Qualifications and Skill Requirements:
This role is crucial for ensuring that products and processes comply with internal standards as well as external regulatory requirements, including ISO 13485. The ideal candidate should have a strong background in validation processes, quality systems, risk management and regulatory compliance within the medical device or IVD sector. IVDD/IVDR compliance knowledge advantageous. Proficient in validation methodology, including process, cleaning, test method, and spreadsheet validation. Familiarity with risk management principles and practices in a regulated environment. Excellent analytical, problem-solving, and organizational skills. Science based degree beneficial. Managing timelines and prioritising workload to meet business needs. Good interpersonal and communication skills. Excellent attention to detail. Highly motivated, proactive and solution focused. The ability to adapt to changing priorities.
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Published on: Oct 18, 2024 Country: United Kingdom Location: Dartford Job Category: Quality Employment type: Regular Full Time Summary
In this role you will oversee and coordinate the Site Validation Programme. This will involve: leading and coordinating the Site Validation Review Board, overseeing the implementation of the S-VMP and managing and supporting Validation activities for new and existing Site validations. Responsibilities:
Oversee and coordinate the site Validation Programme. Lead and coordinate the site Validation Review Board, overseeing the implementation of the S-VMP. Manage and support Validation activities for new and existing site validations including: Process Validation: Develop, execute, and maintain validation protocols and reports for all manufacturing processes in accordance with ISO 13485 and IVDR regulations. Cleaning Validation: Establish and perform cleaning validation protocols and studies to ensure compliance with company and regulatory requirements, ensuring the cleanliness of manufacturing equipment and environments. Test Method Validation: Validate and verify analytical and testing methods to ensure they are suitable for their intended use, producing reliable and reproducible results. Spreadsheet Validation: Conduct validation of spreadsheets used for data handling and analysis to ensure accuracy and compliance with regulatory standards. Contribute to project Cross Functional Teams (CFTs) as a Validation subject matter expert, ensuring adherence to validation policies, procedures, safety, and training. As required, liaise with engineering and external vendors regarding equipment User Requirements Specifications (URS’s), Factory Acceptance Trials (FAT’s) and any other associated validation issues. Develop, execute, and maintain validation protocols, assigning tasks to site personnel as necessary. Review and approve validation documentation to ensure compliance with ISO 13485 and relevant regulatory standards. Responsible for managing site risk management plans and reports, ensuring compliance with regulatory standards and company policies. Actively participate in site projects, including technology transfers and new product development initiatives, ensuring that validation and compliance considerations are integrated from the onset. Prepare for and support internal and external audits, including regulatory inspections. Develop and roll out Validation training for the department and site. Liaise with and seek appropriate advice from the other DiaSorin plants worldwide. Approach the role in a flexible manner and be prepared to adapt to requirements outside of the immediate role that are essential to the organisation. Experience, Qualifications and Skill Requirements:
This role is crucial for ensuring that products and processes comply with internal standards as well as external regulatory requirements, including ISO 13485. The ideal candidate should have a strong background in validation processes, quality systems, risk management and regulatory compliance within the medical device or IVD sector. IVDD/IVDR compliance knowledge advantageous. Proficient in validation methodology, including process, cleaning, test method, and spreadsheet validation. Familiarity with risk management principles and practices in a regulated environment. Excellent analytical, problem-solving, and organizational skills. Science based degree beneficial. Managing timelines and prioritising workload to meet business needs. Good interpersonal and communication skills. Excellent attention to detail. Highly motivated, proactive and solution focused. The ability to adapt to changing priorities.
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