Document Controller

3 days ago

Dublin, Ireland JobContax Full time

Document Controller, Dun Laoghaire, DublinOffice/Project Location:Dun Laoghaire, DublinEmployment Type: ContractWork Location:  Hybrid, 2 or 3 days per week onsitePay: €30 - €38 per hourExperience: 3+ yearsVisa: EU passport or Stamp 4 visa requiredOur client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoighaire, South Dublin. The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment. This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant.Provide structured control and visibility of all documentation required for Operational Readiness across expansion projects This role ensures readiness deliverables (SOPs, training materials, change controls, validation packages) are tracked, version-controlled, and aligned with GMP and network standards. It bridges Capital Project outputs and Operations scope to avoid duplication and ensure audit readiness.Document Control & GovernanceMaintain Smartsheet or equivalent trackers for Operational Readiness documentation (e.g., SOPs, TRNs, APPXs, FMEAs, MES recipes).Ensure version control, metadata accuracy, and timely approvals in CDOCS and other ADL systems.Prepare documentation packages for Go/No-Go readiness reviews and regulatory inspections.Tracker ManagementOwn and update Operational Readiness document tracker (e.g., ADL1X Doc Tracker) to provide high-level visibility of scope and progress.Monitor readiness deliverables linked to milestones (e.g., FAT, SAT, PPQ, media fill readiness) and escalate delays.Interface & CoordinationLiaise with functional leads (Manufacturing, QA, Validation, Automation, Supply Chain) to collect and verify documentation inputs.Support weekly Ops Readiness governance meetings with dashboards and gap reports.Interaction with Readiness WorkstreamsCollaborate with Training team to ensure SOPs and curricula are approved and scheduled.Coordinate with MES and Automation teams for recipe readiness and system documentation.Work closely with Validation to track protocol execution and approval status.Operational Readiness SupportAlign documentation scope between Ops Readiness and Capital Projects to prevent duplication.Assist in preparing turnover packages for operational handover and Go-Live readiness.KPIs% of readiness documents approved without rework.Timeliness of readiness deliverables vs. project milestones.Completeness and accuracy of document trackers.Requirements3+ years in document control or readiness coordination within GMP manufacturing or large-scale projects.Familiarity with Operational Readiness frameworks and GMP documentation standards.Proficiency in Smartsheet, CDOCS, SharePoint, and Microsoft 365 tools.Knowledge of change control strategy and readiness governance processes.PackageContract role - Hourly rate €30 - €38 per hourMinimum 12 month contractHybrid role 3 days per week onsiteOnsite Expectations: 2 to 3 days per week

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