NRL’s client based in Irvine is looking to recruit a Quality Validation Specialist for an initial 3 month contract on a PAYE basis.
About the role
- Lead & Support the Validation and Life Cycle maintenance of Site computer systems and analytical equipment in line with site regulatory requirements. Supports the wider company network in the computer systems area.
- Coordinate, laed and support the compliance activity in preparation for any regulatory audit and in response to current and any subsequent legislation affecting computer systems validation analytical equipment validation electronic records and electronic signatures this involves an approval an advisory role with respect to assessments and follow up corrective actions
- To provide the necessary support as required for all levels of corporate customer and regulatory audits including face to face interaction with inspectors during internal and external regulatory audits
- to deliver standardised training materials on computer systems an analytical equipment validation topics and delivered training as required
- support standardisation of computer systems an analytical equipment validation processes, supporting roll out and adherence to these standard validation processes to deliver consistency and agility with cost benefits
- To understand the impact on ways of working relevant to computer systems and analytical equipment validation as required through changes in legislation.
- As a technical specialist advising the Department site and function on technology issues this will involve delivering regular and appropriate training on computer system regulations and analytical equipment regulations
- Support and development and use of systems within the wider company networks and maintain links with central IT, quality, shared services and other sites
What you will need?
- HND level qualification or equivalent in either a science or engineering subject
- expert knowledge of validation in alignment with QMS, cGMP, GQLP and cGxP requirements
- Abroad multidisciplined knowledge of computer hardware, software, relational databases and other technology
- Experience in a regulated quality driven process environment
- Specialist knowledge of validation