Document Controller

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 / working with an Electronic Document Management System and responsible for 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 Operation 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 investigation 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 / working with an electronic Document Management System
• Minimum 3 years experience working in Document control in a Pharmaceutical GMP environment.

Please note, we do not require agency assistance with this role.