Back to Job Search
  • Location: Edinburgh
  • Salary: Competitive Salary plus benefits
  • Job Type:Permanent

Posted 18 days ago

  • Sector: Quality
  • Contact: Adrienn Prezenszki
  • Contact Email: adrienn.prezenszki@nextphaserecruitment.com
  • Contact Phone: 01403 216216
  • Start Date: 2022-06-14
  • Job Ref: V-47385
Are you an experienced individual in validation in a GMP environment within the pharmaceutical industry?


If so, there are 2 x newly created permanent opportunity available for Validation Specialists to become key members of the Validation team and undertake a range of related to facilities, equipment, and process validation.


The company is creating cutting – edge therapies to help change people’s lives in their state-of-the-art GMP manufacturing facility in Edinburgh.


The Role:

You will be responsible for facility, equipment and process validation activities including preparation and execution of validation protocols and reports.   

Key Responsibilities:

  • Planning, co-ordinating and executing (as appropriate) validation activities including facility and equipment validation, qualification, and re-verification.
  • Completion and review of quality related documentation including validation documents, change controls, incidents/deviations, and risk assessments in line with GMP and SOPs.
  • Preparation and execution of validation protocols and reports.
  • Contribution to the set up and execution of the Validation schedules, including the development and maintenance of the Validation Master Plan.
  • Development and implementation of process improvements relating to Validation activities.
  • Assisting with the procurement and management of out-sourced Validation and qualification service providers.
  • Ensuring Validation and re-qualification schedules are co-ordinated and communicated.
  • Routine maintenance of KPIs and data to enable reporting on Validation status and performance of Validation activities.
  • With the Validation team, providing regular reports to management on Validation activities.

Experience:
  • You will have a Life Science degree and 3 or more years’ experience working within a GMP manufacturing environment within a pharmaceutical or biopharmaceutical company working with biologics etc.  
  • You must have experience in validation programmes related to equipment, facility, process validation ideally within a sterile manufacturing facility
  • You would ideally have experience working with quality management systems and compliant with FDA, UK, EU regulations
  • You need to have strong attention to detail and excellent communication skills