Job Description
We are seeking a skilled Quality Documentation Specialist for a 12-month Fixed Term Contract based in Kilkenny.
The successful candidate will be responsible for ensuring compliance with operating standards and regulatory requirements, particularly in documentation practices.
The ideal candidate will hold a degree in science or engineering and have at least three years of experience in quality assurance, quality systems or compliance and documentation. Prior experience in quality system audits and documentation is essential. You will work collaboratively as part of a team and liaise across different divisions on site.
Responsibilities:
* Review daily production & quality record logbooks for product release.
* Compile and review QC and manufacturing batch records for compliance to cGMP.
* Control site documents, document revision management, QA operations logs and quality database.
* Logbook creation, logbook archiving and management.
* SOP workflow management.
* Control of changes to documented procedures.
* Completion of documentation audits.
* Support training to relevant employees.
* Ensure quality data and documentation is complete and maintained and available for internal and external inspection.
* Reporting on documentation metrics.
* Support improvement projects.
Please note that Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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