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Senior Validation Specialist

Senior Validation Specialist

  • Location

    Liverpool

  • Sector:

    Scientific, Pharmaceutical & Chemical

  • Job type:

    Contract

  • Salary:

    £39000 per annum

  • Contact:

    Johnathan Miller

  • Contact email:

    Johnathanm@scantec.co.uk

  • Contact phone:

    +44 (0)151 666 8968

  • Job ref:

    84548

  • Published:

    6 months ago

  • Duration:

    12 months initially

  • Expiry date:

    2020-07-02

  • Start date:

    As soon as possible

Senior Validation Specialist – RT-PCR assay development
£39,000 equivalent per annum
12 month contract initially
Based in Liverpool

A multinational Pharmaceutical company is looking to appoint an experienced Senior Validation Specialist to optimize, develop and validate an RT-PCR based assay at their site in Liverpool.  The role is part of ongoing expansion 

Senior Validation Specialist Duties:
  • Performs tests in accordance with established methods and properly documents test results
  • Provides guidance /training to other lab staff as required
  • Authors protocols and reports for suitability studies and investigations to support testing and compliance issues
  • Ensures laboratory instruments are qualified, calibrated and properly maintained and documentation complies with cGMP standards
  • Assists and maintains standard operating procedures (SOPs), risk assessment and other documentation as necessary
  • Documents quality issues and performance measures for management review
  • Uses technical expertise to overcome analytical issues
  • Makes data supported decisions on project progression
  • Leads and develops a strategy, plans and manages project delivery
  • Documents project work as detailed lab book records or under technical protocols and reports as appropriate
  • Evaluates performance of analytical instruments and equipment and recommends new acquisition or replacements
  • Disseminates project findings/status updates at regular meetings/ forums within the Global Analytical, Science and Technology department
Qualifications and Experience:
  • Bachelor degree in a relevant scientific discipline with 6-8 years experience
  • Masters with 4-6 years experience
  • PhD with 2-4 years experience
The role holder:
  • Is an expert in nucleic-acid based assay validation – direct experience of RT-PCR assay development, DNA extraction and optimisation
  • Demonstrates ability to work in a regulated environment (biologics, diagnostics or other) - experience of applying ICH Q2 Validation principles or ISO/WHO equivalent
  • Has experience of transfer of assays across labs/Sites
  • Is an independent worker - Ability to trouble shoot and serve as SME
  • Showcases excellent technical writing skills
  • Has experience of supporting regulatory submissions
  • Has experience of robotic/automated DNA extraction modules (desirable)
To apply please send your CV into Johnathan Miller at Scantec via johnathanm @ scantec. co. uk


 




Scantec Personnel Limited is acting as an employment business and an employment agency. For contract or interim roles (and unless otherwise stated), all pay rates stated are on a Limited Company basis (outside IR35 Determination). Agency PAYE and Umbrella engagement models are also available, which will result in a different pay rate than advertised above.
 
 
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