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.
- 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