Role Purpose:
* A new vacancy has arisen for a Document Controller to join our client’s site based in Co. Tipperary.
* The Document Controller will be responsible for implementing and working with an Electronic Document Management System and for the issuance and control of GMP documents for all production and related activities (e.g., sampling, testing, qualification).
Core Duties and Responsibilities:
Responsibilities include, but are not limited to, the following:
* Implementation and working with an Electronic Document Management System.
* Issuance and control of documentation for production – batch records, logbooks.
* Issuance and retrieval of site standard operating procedures.
* Issuance of qualification documents to engineering/validation departments.
* Issuance and control of QC/ARD specifications, methods, protocols, and artwork specifications.
* Archival and storage of all documentation and maintenance of the document storage area.
* Prepare standard operating procedures, reports, and forms as required.
* Lead any investigations related to document control.
* Provide support to quality management, QMS, and training departments.
* Perform process audits for GMP compliance.
* Support during regulatory/customer/corporate audits as required.
Education & Qualifications Required:
* Minimum Level 5 qualification.
* Experience in implementing and working with an electronic document management system.
* Minimum 3 years' experience working in document control in a pharmaceutical GMP environment.
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