Validation Support Officer FTC in Merseyside, Merseyside, United Kingdom

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.

Role:

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.

Person:

  • 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

Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our Privacy Policy h t t p s : / / w w w . r u s s e l l - t a y l o r . c o . u k / p r i v a c y - p o l i c y on our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or the GDPR please contact us on h r @ r u s s e l l - t a y l o r . c o . u k

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