Quality Compliance Specialist
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| Job Type | Fixed Term |
| Area | Dublin, Ireland |
| Sector | EngineeringQuality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #1002295 |
| Job Views | 114 |
- Description
- We are currently recruiting a Quality Compliance Specvvialist on a FTC for our client’s site in Dublin. Reporting to the QA Associate Director, this is a technical role that will primarily focus on the oversight of the program for electronic system compliance onsite. This role is linked to the Quality Management System and Data Integrity program. You will apply skills and knowledge to recognise and resolve issues that impact efficiency, throughput, quality, and/or the fulfilment of the assigned performance targets.
Why you should apply:
Our client has developed a culture of innovation, inclusion and development, and consistently features as a great place to work.
What you will bedoing:
Manage and drive data integrity and data governance requirements for all Operational Information and Automation systems across the Business Unit incl. Operations, Laboratories, and QA systems
Support the QA Data Integrity Specialist with ongoing data integrity remediation activities on the site Quality Improvement Plan
Generation and routing of data mapping processes, risk assessments and criticality assessments in conjunction with QRM through the Quality Assurance process.
Complete data governance reviews and subsequent remediation activities of business unit systems and processes.
Generate data process maps to describe the data flows throughout the systems and to identify critical data control points/transactions.
Assist in data integrity investigations onsite as required, complete validation activities to ensure new and existing equipment/ systems and meet and maintain Annex 11, 21CFR Part 11 and GAMP5 requirements.
Partner with remediation activities including any potential validation activities to address identified process and/or equipment data governance gaps.
Lead and/or assist the development of critical alarm matrix for systems which will lead into procedural controls.
Develop training modules to continue the upskill and awareness of data governance across the business unit.
Updating of the current system risk assessments and risk mitigation plans. Completion of risk assessments for new installs.
What you need to apply:
Minimum of Level 8 in Science, Engineering or Quality Qualification.
Some exceptions made for those candidates demonstrating equivalent knowledge and having substantial pharmaceutical QA experience.
Experience working in a relevant area within a manufacturing or GMP regulated environment
Minimum of 3 years’ experience in a highly automated manufacturing environment
Experience in using TrackWise, SAP, Microsoft Word, Excel and Outlook
Experience with a proven record of cross functional project delivery
Systems background: ERP, MES, Data Historian (OSI PI), Chromatography (Empower) and laboratory management systems
