Job Description
We are seeking a Quality Documentation Specialist for a 12-month Fixed-Term Contract 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 at least 3 years' experience in quality assurance, quality systems or compliance and documentation. Prior experience in quality system audits and documentation is essential.
Responsibilities:
* Review daily production & quality record logbooks for product release.
* Compile and review of 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.
* Supporting the team on overall site KPIs.
* Support improvement projects.