Document Controller

Document Controller

Industry : Pharmaceutical

Job Summary:
Document Controller 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.

Essential Duties and 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 and Experience:

• Minimum Level 6 Qualification.
• Experience in implementing / working with an electronic Document Management System.
• Minimum of 3 years experience working in Document control within a Pharmaceutical GMP
  environment.

Contract Duration:  Permanent

Location:  Co Tipperary