Acorn is looking for a Validations Manager for one of our NHS clients in the Cardiff area.
You will be a member of a national Quality Management Service for Pathology. The service is putting into place a quality management system certified to ISO9001 underpinned by an electronic QMS for document management. The post holder will lead the design and implementation of the validation of the new LIMS service in accordance with the Good Automated
Manufacturing Practice (GAMP) 5 approach to compliant GxP computerised systems. They will be a key player, able to influence how to take the work forward.
* Designing, developing and implementing computing systems validates policies and process for the LIMs service
* Ensuring and maintaining regulatory compliance of the LIMS systems and services for the requirements of computer systems validation through developing strategies, plans, protocols and reports, managing projects and assessing the quality of work undertaken
* Meeting with inspectors at inspections and assessments as the front face for LINC for key aspects of computer system validation
* Planning and performing internal Computer Systems Validation audits applying advanced levels of investigative processes and knowledge of Computer Systems Validation, compiling detailed audit reports and managing the identified outcomes across the organisation
* Lead and manage two Test Analyst / Trainers and a Validation Officer and have day to day and line management responsibility for these staff
Ideal Candidate will have:
Experience of managing Computer Systems Validation, as assessed by national regulatory bodies including the Medicines and Healthcare products Regulatory Agency (MHRA).
Welsh speaking is desirable
This position is available as a permanent contract and is available full time but part-time will be considered. Based at River House although staff are currently working at home.
Pay Rate: £21.67 an hour
Working Hours: 37.5 hours weekly
If you are interested in this position, please apply now and we will contact you to discuss.
Acorn Recruitment acts as an employment agency for permanent recruitment.