Description
One of the top 10 best companies to work for in Ireland is looking for an Automation and IT Quality Lead for their large-scale new facility north of Dublin. Is this you?The Automation and IT Quality Lead is required for an initial 12-month contract.
An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project. This fantastic client offers the opportunity to work within a large-scale environment with cutting edge technology.
The IT Quality Lead is responsible for ensuring Automation and IT systems are complaint to company policies, Sarbanes-Oxley, FDA 21 CFR 11 and EU Annex 11 requirements. This includes developing standard processes and procedures for computer system operation and maintenance.
Role and responsibilities:
- Maintains an approved inventory of site Automation and IT systems.
- Ensures that all Automation and IT systems are configured correctly on the IT call tracking and issue resolution systems.
- Agrees the site strategy and processes for IT and Automation Standard Operating Procedures and Work Instructions to ensure systems have required operation and maintenance activities in place.
- Manages a schedule of required periodic activities to ensure they are completed on time eg Disaster Recovery Testing, Periodic Reviews, User access reviews, data archive activities, etc. (performance monitoring)
- Creates weekly management status reports for commitments including Training, CAPA, CMMS and Change Control. (add in change control champion)
- Creates monthly reports on compliance KPI's.
- Works closely with the validation and quality departments to ensure that site computer system requirements are clearly specified and that the computer system validation life cycle has the necessary controls in place to ensure adherence to compliance requirements.
- Supports the development of a world class compliance culture and focus on continuous improvement.
- Bachelors or Master's Degree in Engineering, Information Systems, Computer Science or the Life Sciences. (need someone technical who has CSV experience)
- At least 8 years' experience in computer system validation and/or compliance within the pharmaceutical industry.
- Experienced in assessment and remediation strategies of systems to meet computer system Sarbanes-Oxley, 21 CFR 11 and EU Annex 11 requirements.
- Experienced with IT Infrastructure, Process Automation, Laboratory systems and Enterprise systems.
- Experienced in the development and presentation of strategies to senior management.
- Thorough knowledge of Pharmaceutical Industry Regulations (cGMP/cGLP, OSHA, EPA/EQB) required.
- Certification in auditing with ITIL/ISO preferred.
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