Snr Document Control Associate
Initial 12 month contract with our pharmaceutical client in South Dublin. The purpose of the role is to provide structured control and visibility of all documentation required for Operational Readiness across site 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.
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.
Required:
* 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.
* Preferred
* Knowledge of change control strategy and readiness governance processes.
Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organizations throughout Ireland; for more information go to www.berkley-
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone David O'Connell at or send your CV to
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