Senior Validation Specialist

Our client a global biotech company based in Speke are looking for an AS&T Senior Validation Specialist to join their QC Analysis team.

This role is lab-based and focused on the optimization, development and validation of an RT-PCR based assay.

This is a temporary role to start 24th May - 37.5 hours per week

Key Responsibilities:

  • 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 Global AS&T

Key Experience/Skills:

  • Bachelor degree in a relevant scientific discipline with 6-8 years experience
  • Masters with 4-6 years experience
  • PhD with 2-4 years’ experience
  • 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)

Required skills

  • Assay Development
  • Pharmaceutical
  • Validation

Application questions

Do you have experience of applying ICH Q2 Validation principles or ISO/WHO equivalent?
experience of transfer of assays across labs/Sites?
Do you have experience of supporting regulatory submissions?
Are you an expert in nucleic-acid based assay validation?
Do you have experience of robotic/automated DNA extraction modules?

Reference: 42676075

Bank or payment details should never be provided when applying for a job. For information on how to stay safe in your job search, visit SAFERjobs.

Report this job