Software Validation Specialist

2 weeks ago


Winsford, Cheshire, United Kingdom Advanced Medical Solutions Full time

Job Title: Software Validation Specialist

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About the Role:

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We are seeking a highly skilled Software Validation Specialist to join our team at Advanced Medical Solutions. The successful candidate will be responsible for ensuring compliance with regulatory requirements and internal standards for Computer System Validation (CSV) activities across the business.

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Key Responsibilities:

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  • Support the validation and revalidation of software systems and applications to ensure compliance with regulatory standards and internal policies.">
  • Conduct and document risk assessments for software systems to identify and mitigate potential compliance issues.">
  • Monitor and manage change control processes related to software systems, ensuring changes are validated and documented appropriately.">
  • Plan and execute periodic reviews of computerised systems to ensure continued validation and adherence to regulatory requirements.">
  • Support the development and implementation of standardised procedures, templates, and policies for CSV processes across the AMS Group.">
  • Provide guidance and training to teams on CSV requirements, ensuring alignment and understanding across all stakeholders.">
  • Conduct audits and assessments of software validation processes and documentation to identify gaps and opportunities for improvement.">
  • Support the successful execution of quality strategies, including harmonisation of computerised systems and related validation processes.">
  • Ensure effective communication and coordination with AMS sites to implement consistent validation practices and regulatory compliance.">
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Requirements:

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  • A bachelor's degree or equivalent in a scientific discipline, with a minimum of 2 years of experience in the medical device or pharmaceutical industries.">
  • Proficiency in applicable Quality System Regulations and ISO quality requirements (Medical Device experience preferred).">
  • Strong understanding of Computer System Validation (CSV) requirements and processes.">
  • Experience with software validation standards, including GAMP and 21 CFR Part 11.">
  • Demonstrated ability to maintain compliance in software systems through effective validation and lifecycle management.">
  • Familiarity with quality improvement initiatives and tools to track, analyse, and report progress.">
  • Ability to manage multiple projects, prioritise tasks, and meet deadlines effectively.">
  • Proficiency with Microsoft Office tools, including Word, PowerPoint, and Excel.">
  • Analytical and detail-oriented approach to risk assessments and validation activities.">
  • Familiarity with tools for data analysis and documentation in software validation contexts.">
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Salary: £55,000 - £65,000 per annum, depending on experience.

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Location: Winsford, UK.


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