Job Description
I am currently seeking a quality documentation specialist for a 12-month FTC based in Kilkenny.
You will be responsible for ensuring compliance with operating standards and regulatory requirements, specifically for documentation practices.
The successful candidate will have a degree in science or engineering with minimum 3 years' experience in quality assurance, quality systems or compliance and documentation. Prior experience in quality system audits and documentation is essential. You will work will as part of a team and liaise across different divisions on site.
Responsibilities:
1. Review daily production & quality record logbooks for product release.
2. Compile and review of QC and manufacturing batch records for compliance to cGMP.
3. Control site documents, document revision management, QA operations logs and quality database.
4. Logbook creation, logbook archiving and management.
5. SOP workflow management.
6. Control of changes to documented procedures.
7. Completion of documentation audits.
8. Support training to relevant employees.
9. Ensure quality data and documentation is complete and maintained and available for internal and external inspection.
10. Reporting on documentation metrics.
11. Supporting the team on overall site KPIs.
12. Support improvement projects.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
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