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