Description
A Global Biotech organisation currently requires an experienced Documentation / Change Control Coordinator to work at their facility in Ireland.The successful Documentation Coordinator will be working on a new project for a new syringe filling line / Packaging building and alterations required to their existing buildings to support this. The project: new build syringe line (3 storey building) and product transfer into the existing vial line on-site, is around ?200 million value project.
Responsibilities:
-Coordinate and Track all IS/Automation lifecycle documentation
-Update of Automation Document Register
-Filing of hard and soft copies of approved documentation
-Transfer approved vendor documents to Site Documentation System
-Carry out the coordination and tracking of IS/Automation Change Controls
-Assign Change numbers and tracking status of all open change controls via the Change Control Log
-Review & Filing of executed change controls
Tracking IS/Automation Test Document Execution
-Record actual progress verses target
-Review of Executed Test Documents for completeness and compliance with GMP
GAMP Computer System Operational Procedures:
-Experienced in the use of EDMS
-Support development of IS/Automation SOP`s.
Experience Required:
-Good Communicator
-Strong Planning, organising and prioritisation skills
-Proficient use of MS Office Applications