Software Validation & Quality SpecialistResponsible for ensuring all equipment and software qualification activities are completed in compliance with global/site procedures, regulatory requirements, and quality standards. This includes providing guidance across the full software lifecycle, covering equipment with software, standalone software systems, spreadsheets, reporting tools, and AI-based applications.
Key responsibilities include
- Leading and supporting software validation and equipment qualification activities from user requirements through risk assessment, testing, qualification, implementation, and ongoing compliance.
- Reviewing and approving qualification lifecycle documentation to ensure systems are validated and fit for their intended use.
- Providing expertise in CSV, Data Integrity, 21 CFR Part 11, Electronic Records & Signatures, and industry regulatory requirements.
- Ensuring all new systems, modifications, deviations, and change controls are managed and documented in accordance with quality procedures.
- Partnering with cross-functional project teams to drive validation activities, resolve quality issues, and maintain project timelines.
- Delivering training and guidance to improve organisational competency in validation and software quality practices.
- Driving continuous improvement, automation initiatives, and a Right First Time culture to enhance patient safety, product quality, efficiency, and compliance.
- Supporting departmental and site-wide quality excellence initiatives while maintaining full adherence to the Quality Management System.
- Required Background &
Skills
- Degree in Software Engineering, Electronics, Computer Science, Engineering, or a related technical discipline.
- Experience within a highly regulated environment such as Medical Devices, Pharmaceuticals, or combination products.
- Strong knowledge of Computer System Validation (CSV), Equipment & Software Qualification, Software Development Lifecycles, Risk Management, and Validation Methodologies.
- Experience developing and reviewing validation documentation including user requirements, risk assessments, qualification protocols, and performance testing.
- Understanding of Data Integrity, 21 CFR Part 11, and Electronic Records/Electronic Signatures requirements.
- Exposure to technologies such as Python, C#, C++, Java, VB.Net, SQL, Power BI, Power Automate, and AI applications is advantageous.
- Experience supporting products in regulated sectors such as medical devices, drug-device combination products, or coated stent technologies is highly desirable.
- Working Arrangement: Primarily onsite initially, with potential flexibility for a hybrid setup in the future.
- Desired Skills and Experience
- Software Validation & Quality Specialist
- Responsible for ensuring all equipment and software qualification activities are completed in compliance with global/site procedures, regulatory requirements, and quality standards.
- This includes providing guidance across the full software lifecycle, covering equipment with software, standalone software systems, spreadsheets, reporting tools, and AI-based applications.
Key responsibilities include
- Leading and supporting software validation and equipment qualification activities from user requirements through risk assessment, testing, qualification, implementation, and ongoing compliance. * Reviewing and approving qualification lifecycle documentation to ensure systems are validated and fit for their intended use. * Providing expertise in CSV, Data Integrity, 21 CFR Part 11, Electronic Records & Signatures, and industry regulatory requirements. * Ensuring all new systems, modifications, deviations, and change controls are managed and documented in accordance with quality procedures. * Partnering with cross-functional project teams to drive validation activities, resolve quality issues, and maintain project timelines. * Delivering training and guidance to improve organisational competency in validation and software quality practices. * Driving continuous improvement, automation initiatives, and a Right First Time culture to enhance patient safety, product quality, efficiency, and compliance. * Supporting departmental and site-wide quality excellence initiatives while maintaining full adherence to the Quality Management System.
- Required Background & Skills * Degree in Software Engineering, Electronics, Computer Science, Engineering, or a related technical discipline. * Experience within a highly regulated environment such as Medical Devices, Pharmaceuticals, or combination products. * Strong knowledge of Computer System Validation (CSV), Equipment & Software Qualification, Software Development Lifecycles, Risk Management, and Validation Methodologies. * Experience developing and reviewing validation documentation including user requirements, risk assessments, qualification protocols, and performance testing. * Understanding of Data Integrity, 21 CFR Part 11, and Electronic Records/Electronic Signatures requirements. * Exposure to technologies such as Python, C#, C++, Java, VB.Net, SQL, Power BI, Power Automate, and AI applications is advantageous. * Experience supporting products in regulated sectors such as medical devices, drug-device combination products, or coated stent technologies is highly desirable.
- Working Arrangement: Primarily onsite initially, with potential flexibility for a hybrid setup in the future.
