The Systems Validation Specialist role is a hands-on position and you will need to be able balance multiple project-based activities, coordinating the generation, review and execution of validation protocols with the relevant stake-holders.
As the Systems Specialist, you will also have an input into projects where there is a significant computerised / software content, ensuring that systems have been appropriately designed and qualified to ensure effective and compliant operational use. You will also lead and execute validation activities of computerised systems and associated equipment in accordance with current regulatory requirements and minimize business risk associated with the processing and storage of electronic documentation ensuring continuity over the equipment and product’s life cycle.
In your role as the Systems Specialist you will take the lead in computer system validation and compliance, managing and delivering specific Validation Projects according to the business priorities, including work scheduling and supervision of junior members of staff so you must be comfortable working alone or within the matrix management system.
You'll be tasked with the continuous improvement of validation systems and procedures to ensure efficiency and best practice within the industry and to stay abreast of changing regulatory expectations, which will mean you will need to write, review and approve validation documentation including protocols and reports and manage the timely closure of any discrepancies or non-conformities.
Educated to BTEC National Certificate or equivalent, including science, you will have substantial experience of generation, execution and review of validation protocols, reports and technical documents, as well as experience of validation life cycle activities for computerised systems. Experience of working within a GMP quality system and dealing with internal customers, identifying and delivering work programs is essential.
A comprehensive understanding of EU and FDA regulatory requirements, an understanding of GAMP processes as well as a technical understanding of computerised systems including PLCs, SCADA, networked systems, laboratory systems, databases, layered software as used in a GxP environment is also crucial.
For more information and a full job spec please apply with your CV or give Sophie or Loren a call on 01722 334433