About Your New Employer
A third level education institution in Galway are hiring for a Validation Officer. The purpose of this role is to lead the Computer System and Process validation processes for a busy research centre and lab.
This is a fixed term 12-month contract. A hybrid working model may be reviewed upon successful completion of the probationary period.
About Your New Job
As a Validation Officer you will…
- Deliver expertise and lead on all validation processes for the units including CSV processes and process validation as required. This includes validation of imaging and analysis software, image transfer systems, Electronic Data Capture (EDC) systems and software, randomisation software, electronic document management systems, study management systems, and aspects of data validation.
- Lead and coordinate multiple validation and qualification activities with various research units and external vendors taking a risk-based approach to validation.
- Lead creation of user requirements specifications, technical specifications and validation reports in accordance with regulatory requirements.
- Maintain validation processes within the quality system in collaboration with QA personnel to ensure that studies carried out are conducted in accordance with Good Clinical Practice (GCP) standards, national and international legislation and meet the quality needs of unit personnel.
- Adherence to the requirements of GCP, ISO 14155, GDPR and all associated regulatory, ethical and legislative requirements in the execution of the research programme.
- Coordinate and deliver mandatory Computer System validation training for unit staff, including CSV training as required.
- Monitoring the validated state of all systems that require validation and working with the Quality Manager to ensure that they are validated, and maintained in a validated state, according to the SOPs
- Manage the CSV change control process and controlled software installation and updates relating to clinical research in associated units.
- Managing the validation of the functional aspects of the system such as installation, database connection etc.
- Contribute to the implementation and oversight of security protection for associated systems.
- Develop, review and approve computer system policies and procedures ensuring compliance with cGMP’s, lab policies and procedures and regulatory requirements (21 CFR Part 11, Annex 11)
- Implement continuous improvement to associated processes as required.
- Contribute to associated procurement activities as required.
- Support regulatory inspections and internal audits.
- Contribute to the investigation of associated non-conformances and implementation of corrective and preventative actions.
- Any other duties that arise within the ambit of the post.
What Skills You Need
- Bachelor’s degree in a scientific, engineering or healthcare field
- 4+ years’ experience working within a regulated quality management system in a similar role
- Extensive knowledge of validation deliverables associated with each step of the computer system life cycle including FDA and European compliance regulations and GAMP guidelines
What’s on Offer
- 57k + (Grade 5 pay scale in line with Government policy)
- Pension
What’s Next
Apply now by clicking the “Apply Now" button or call me, Lauryn Flanagan on +353 91 455306
Or if the job isn’t quite right but you are looking for something similar, please get in touch. We also have multiple Temp, FTC and Contract jobs available.
