Data Integrity Manager

Job Ref: J26073
Sector: Clinical
Sub-sector: Medical Devices
Date Added: 28 March 2018
  • Kings Lynn, Norfolk, England, UK
  • £52,000 - £62,000 per Annum
  • Laith Mustafa
  • 0161 868 2231

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Data Integrity Manager - Medical Devices - NorfolkDo you have extensive knowledge of regulatory expectation for Data Management and the drive and interpersonal skills required to deliver on our business wide Data Integrity improvement strategy?The data that our business captures and uses ensures that our devices are safe for patients to use every day. We are investing in our processes, practices and systems to ensure the integrity of our data and to maximise how we use our data to inform business decisions. As our new Data Integrity Manager you will lead the company's efforts to develop and maintain compliant data management practices and will play a key role in the development of efficient QMS for the capture and use of data. As a Data Integrity Manager you will be responsible for * The development of approach and policies to guide the company to develop robust compliant * Coordinating project activities * Manage the requirements, selection and subsequent development/validation of future data management systems such as LIMS * Ensuring systems are validated and robust in meeting business/regulatory needs * Developing personnel in Computer Systems Validation * Increasing awareness of data integrity and requirements * Performing and managing GAP analysis for 21 CFR part 820, EUDRALEX volume 4 and ISO13485:20116 About you Naturally you are a "people person", able to communicate effectively with a wide range of audiences both in writing and verbally. A proven project manager who will utilise your excellent interpersonal skills to motivate and influence colleagues across the business. On a technical side you have extensive knowledge of the regulatory expectations for Data Integrity with detailed knowledge of 21 CFR Part 11, 21 CFR part 820, EU Annex 11, ISO13485 and GAMP. As well as regulatory knowledge you have a demonstrable track record of managing and delivering complex projects with multiple stakeholders and have extensive experience in computerised systems software validation. You have significant experience in laboratory and metrology validation and risk management process. For more information, please call Laith Mustafa on 0161 868 2231 or email

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.