Validation Specialist, Open to flexible working

3 days left

Stevenage, Hertfordshire
13 Nov 2020
30 Nov 2020

Secondment/Contract: End of 2021

This opportunity exists within Validation team in CGT in Stevenage facility. As validation Specialist you will Support the validation of R&D Cell and Gene Therapy QC laboratory and manufacturing to implement, and validate equipment and processes supporting the new GMP manufacturing facility. Validation knowledge is preferred especially design of protocols, execution of protocols and deviation investigation. A can-do attitude is a must, and knowledge of scale up is a benefit.

Key Responsibilities:

  • Execute the validation and qualification of CGT QC Lab
  • Execute validation and qualification activities in the new manufacturing facility
  • Demonstrate the GSK Values and Expectations with focus to patient safety, product quality, and record integrity
  • Developing efficient compliant ways of working to ensure maintenance of the QC laboratory MHRA license
  • Supporting license activities for the new manufacturing facility
  • Supporting System owners in preparing User Requirement specifications and system/equipment selection.
  • Preparing validation plans, assisting system owners with impact assessment and identifying validation requirements in accordance with QMS expectations, and regulatory standards.
  • Writing Validation protocols and reports.
  • Perform validation activities described in validation protocols.
  • Work in a cross functional team to execute validation protocols.
  • Reviewing the results of validation studies, investigating deviations, establishing and managing appropriate CAPAs,
  • Ensure and evaluate integrity of records and data for regulated computer systems and confirm it is appropriately incorporated in the system development lifecycle and change control processes as defined by the GxP business processes being supported and the data being managed by those processes.

Job Requirements:

  • Bachelor's in engineering, Sciences or related discipline or substantial practical validation experience
  • Good technical writing skills
  • Collaborative working experience
  • A working knowledge of Cell and Gene Therapy/Biopharmaceutical is desired, but experience in sterile production, microbiological assays or other relevant experience will be considered, please be specific in your application regarding these points

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