AIQ Remediation Lead
Ireland is a hive of activity for the Life Sciences Industry at present with no shortage of major expansion/ new build facilities. We have an exciting opportunity for an AIQ Remediation Lead to join a major project for a global pharmaceutical organisation, located in the Dublin Region, with great longevity of employment possibility.
- Lead a team responsible for the generate/ update, execute, review and approval of Computer System Validation (CSV) deliverables in line with the AIQ Remediation Plan delivery.
- Investigate and trouble shoot problems which occur to determine solutions or recommendations for improvements or change.
- Work with the system owners and Quality team to ensure that the appropriate Quality standards are applied for all CSV documents and deliverables, consistent with best practice and internal Quality Standards and expectations.
- Provide technical support for the development of electronic data review procedures
- Actively manage the execution of all CSV testing with right first time approach.
- Ensure that any changes in detailed timelines are escalated in a timely manner so that impacts can be proactively assessed and KPI’s maintained..
The ideal candidate will have:
- At least 2 years experience in the planning, document generation, support or execution of CSV activities in a biologic drug substance manufacturing plant.
- A thorough knowledge of regulatory requirements associated with computer systems including EU GMP Annex 11, 21 CFR Part 11 is required.
- Strong knowledge in Data Integrity (MHRA Data Integrity Definitions and Guidance for Industry and PIC/S Guidance Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments).
Due to travel restrictions only candidates based in Ireland will be considered
For more information on this project / position, please apply with a copy of your up to date CV today!
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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