Description
A vacancy exists in the Validation Department, within Quality Assurance for the position of Validation Executive. This will initially be a 6 month contract to provide project secondment cover reporting directly into the Head of Department. The Validation engineer will be responsible for developing, executing and reviewing qualification and validation programmes which meet with appropriate GMP and regulatory requirements.The validation engineer will possess an honours degree or post-graduate qualification in Science/Engineering or other related discipline and will have experience in the Pharmaceutical industry, preferably in validation activities. Previous validation experience of interest includes the areas of Commissioning and Qualification, Equipment qualification, Filling and Packing systems and use of Risk Management Tools.
Specific duties will include:
.Preparation, review and approval of IOQ/PQ protocols/reports for equipment/system qualifications performed by Validation and other departments
.Validation support for New, Lean and Continuous Improvement Projects
.Performance of equipment re-qualification reviews and risk assessments
.Co-ordination/performance of other validation studies as relevant
.Provision of validation assessment for equipment qualification related change controls and deviations
.Adherence to Group Validation Policies/Guidelines and Site Validation Master Plan
.Keeping abreast of/adhere to regulatory requirements
The validation consultant will be a self-starter, possessing excellent interpersonal, team work and communication skills. They will have experience of working to tight deadlines to deliver a challenging programme of work in compliance with regulatory guidelines.