Description
Quality Validation Engineer - RevalidationMy client is a leading global Medical Devices company and they are currently seeking an experienced Quality Validation Engineer to be responsible for the maintenance of the validation process.
The Quality Validation Engineer will be responsible for revalidation/requalification assessments, managing the revalidation/requalifications for required equipment, systems, facilities and processes, he will be required to write and participate in the validation of required validations. He will be responsible for ensuring that site validations adhere to the global and site policies and procedures and for the maintenance of the site validation master plan.
Validation Activities:
Set up and maintenance of the site validation management system
Risk Classification of all site equipment, systems, facilities and processes
Manage the Revalidation/Requalification assessment process
Manage the revalidation/Requalification of site equipment, systems, facilities and processes as required.
Development of protocols, test scripts and associated support documentation
Development and maintenance of the site validation master plan
Adherence to the companies policies and procedures
Carry out all activities in compliance with company Safety & Environmental Standard Operating Procedures.
Experience Required:
Third level qualification in a science, engineering or computing discipline
5+ years experience in a GMP regulated environment or software quality role.
Strong analytical skills with good knowledge of process controls systems
Knowledge of six sigma and lean tools
Self motivated with ability to lead a core team to meet objectives.
Must be familiar with the regulatory requirements of the FDA and/or ISO
Decisive, good communicator, record of achievement and be a good team member.
Experience of executing validations in a GMP manufacturing environment
Experience of scientific report writing including such documents as SOPs, protocols, deviations, reports etc. is essential
Ability to evaluate and assess information to determine appropriate risk and required actions is critical.
Ability to manage multiple priorities
If you are interested in this position please contact me Adele Moran on for more information and click apply now with an updated CV for immediate consideration
To find out more about Real please visit www.realstaffing.com