Ascend PM are hiring a Document Control Associate to join our clients team, a multinational biopharmaceutical company based in Dublin. This is a great Contract opportunity to join a growing team. Initially 12 Month Contract with view to extend. Contact or email CV to to find out more.
Overview:
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.
Key Responsibilities:
* Maintain 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 systems.
* Prepare documentation packages for Go/No-Go readiness reviews and regulatory inspections.
* Own and update Operational Readiness document 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.
* Liaise 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.
* Collaborate 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.
* Align documentation scope between Ops Readiness and Capital Projects to prevent duplication.
* Assist in preparing turnover packages for operational handover and Go-Live readiness.
Experience & Qualifications:
* 3+ 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.
* % of readiness documents approved without rework.
* Timeliness of readiness deliverables vs. project milestones.
* Completeness and accuracy of document trackers.
Why this role matters:
Operational Readiness is critical to ensure smooth transition from project execution to routine operations. This role provides the backbone for documentation compliance and visibility, enabling successful start-up and audit readiness.