About this role
We are looking for a QA Document Controller & Training Admin for manufacturing site in Carrigtwohill , Co Cork.
To provide a Document Control Service and maintenance of the company’s Training Program.
These services are to meet the requirements of in-house procedures and to be executed in compliance with cGMP requirements.
The support and development / assistance (training and support guides) of Document Control systemIssue, control, withdrawal, distribution and destruction of controlled copies of documents for quality departmentCo-ordination of Periodic Document Reviews.Filing of Master Copies of Documents.Problem resolution for Document Control systemSite contact for global SOPs updatesEnsuring that all that above are in compliance with cGMP, global and local procedures and are in a continuous state of audit readiness.Administration for the QA DepartmentIssuing and binding of batch records for Production.Maintain files and archive systems in the QA Department.Ensure office supplies are on hand to meet demand.Withdrawal, distribution and destruction of controlled QA documents.Maintain the system for issuing, reviewing and archiving of QA logbooks.Preparation of QA documents such as SOPs and Quality Agreements etc.To prepare reports, documents, presentations etc. as required.Compilation of KPIs.COE document leadManage, maintain, and update an efficient LMSProvide support to and deputise for Site training Co-OrdinatorImplement corrective actions of retraining due to non-compliance to proceduresAssist with the creation of training related memos, if requiredAssist in preparation of QA Department for Regulatory and Corporate AuditsWork Cross Functionally and Independantly as required to drive continuous improvement Experience of using an EDMS computerised solution is essentialGood PC skills and intermediate level use of MS office is essential (Word, Excel, Outlook & PowerPoint)Previous experience in the pharmaceutical industry The person should be a highly organised, self-starter capable of working as part of a team or on their own initiative AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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