Job description Posted 16 June 2020

Computer Systems Validation Operative – Microbiology Systems & Analytical Systems (MSAS) Systems Compliance

Key Responsibilities

  • GSK are looking for a couple of years’ experience on use of Analytical Equipment and ideally experience of change control and validation for these types of systems. So systems which perform analysis AND have a PC attached which manage data acquisition & control of the instrument. Systems such as FTIR, NIR HPLC, particle size X-ray diffraction. Another advantage would be experience in data historian systems such as Empower, Labware and OpenLAB ECM.
  • You will work with team of experts in compliance, validation of computerised systems and analytical instrumentation to support the validation of computerised systems in a GMP environment.
  • Collaborate with the Systems’ Compliance team to support Windows 10 upgrades & data systems validation
  • Contribute to validation documentation, supporting the implementation of the standard change control templates and feedback on the suitability of the templates.
  • Analyse the systems with the aid of existing validation documentation.
  • Provide metrics to monitor progress of validation and upgrade activities.

Applicant Skills Sought

  • Bachelor’s degree or higher in Physical Science or Knowledge Management
  • Experience in using a range of computerised analytical systems in a GMP lab bases environment, for example Chemstation (UV-Vis), Bruker Opus, Waters etc.
  • Exposure to computer system validation and change control documentation in a regulated environment and the ability to understand and apply the information contained therein.
  • Working knowledge of Data Integrity and GMP practices concerning data in the pharmaceutical or similarly regulated industry.
  • A mindset and desire to use modern technology to improve the efficiency and effectiveness of the processes used to validate computer systems and analytical equipment.
  • Comprehensive training will be provided for specific tasks
  • Role to be based at either Stevenage or Ware

Career Development Opportunity

  • MSAS Systems Compliance is creating a team to help migrate all their computerised analytical systems to Windows 10 and ensure compliance with the latest MHRA guidance on Data Integrity. To assist in this process, a standard pre-approved change control template will be executed for each system, which may involve the creation and execution of further validation documents. These documents will be used by the successful applicants to record the W10 upgrade and the mitigation of gaps identified in each system. This will provide the successful applicants with a basic grounding and valuable experience in computerised systems’ validation, which may lead to work on multiple full validation projects, as experience is gained.

Training Provided

  • There will be formal training provided to execute change control and validation documentation on a range of computerised analytical systems in order to migrate to Windows 10 operating system, close the compliance gaps on each system and keep pace with the schedule. You will work closely with and learn from laboratory automation, analytical chemists, quality experts and validation specialists. You will use modern documentation production and storage techniques to improve and modernize how we document the validation and compliance of our systems. Keeping pace with emerging data standards and validation techniques, you will help to ensure that validation procedures and documentation practices meets or exceeds the quality of our current processes.
  • Quality & compliance has been built into the templates, however a degree of critical thinking and good attention to detail will be necessary for successful candidates. The team is small but multi-disciplinary and you will need to work well with scientists, managers and other technical colleagues outside your field of expertise, therefore excellent communication skills are required.

Additional information about the process

Role is innitialy working from Home

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