Validation Support Officer FTC

Job Title: Validation Support Officer FTC
Contract Type: Contract
Location: Merseyside, England
Salary: £24000 - £26000 per annum
Start Date: ASAP
Reference: J894750_1546519544
Contact Name: Ben George
Contact Email:
Job Published: January 03, 2019 12:45

Job Description

Role: Validation Support Officer (FTC)

Location: North Merseyside

Salary: £25,000 (6 / 12 months FTC)

Russell Taylor Group has a fantastic opportunity for a Validation Support Officer to join a Manufacturing Pharmaceutical Company. You will need to have experience in Quality and Validation within a Pharmaceutical Manufacturing company, ideally at minimum of 3 years. This is a great opportunity to gain more experience in the industry as you progress in your career. Immediate start for the right candidate.


Validation Duties:

  • Review and execution of protocols to support validation work and the subsequent reports to justify the approval of the validation work. Assisting with ICH Q3D Elemental impurities.
  • Process & Engineering Change controls: to ensure the change to the validated system results in a system that is validated post change.
  • To assist in the determination of health based exposure limits for a residual active substance based on the method for establishing the so-called Permitted Daily Exposure (PDE) as described in Appendix 3 of ICH Q3C (R4) Impurities: Guideline for Residual Solvents" and Appendix 3 of VICH GL 18 on residual solvents in new veterinary medicinal products, active substances and excipients.
  • Risk Impact assessments to justify approaches taken with validated systems
  • Process Deviation: assessment of impact, root cause, CAPA: impact of deviations on validated systems must be assessed from a validation perspective
  • Cleaning validation: as per the VMP execute all validation work to cover cleaning validation, clean hold times and dirty hold times for example. Generation of PDE reports.
  • Process Validation: mixing and filling validation. Re-validation as required for existing products and defining the methodology/approach for new products
  • Supporting Validation activities required for Regulatory Submission
  • Support NPD activities by providing validation guidance to project teams

NPD & NPI - Introduction Assessment Duties:

  • Inspection preparation - using GMP knowledge and experience to assist Facility inspection readiness
  • Consultation when preparing change controls and action close out co-ordination
  • Application of knowledge & experience to support colleagues and other Departments as required
  • Undertake such other reasonable duties as may be required from time to time in order to support the Bells Healthcare business.


  • The role owner will have proven Quality / Validation experience within a pharmaceutical manufacturing. It is anticipated that the person will have a minimum of three years practical experience.
  • Demonstrable experience of exerting validation expertise is a requirement.
  • Experience in ICH Q3D Elemental Impurities and PDE is essential to fulfil this role.
  • A Degree in a Life Sciences subject or Engineering would be advantageous

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