Document Controller (Consultant) - Lilly Limerick - Raheen, County Limerick
(2025-09 - 2026-05)
GMP Library Document Controller focusing on Archiving and Control Printing within the Administrative/Quality Assurance department.
- Management of the GMP Library for Archiving, Retention and Destruction of documents and records such as Paper-Based, MEXF (Master Executable FRM's), Controlled Copies and True Copy documentation.
- Responsible for overseeing the management, organization and maintenance of GMP records, ensuring they are archived correctly and accessible when needed.
- Oversaw GMP Library operations, including submission, workflow lifecycle throughout Quality Management System (Veeva Quality), metadata classification and storage allocation to ensure accuracy, traceability, and audit readiness.
- Performed Inventory management through report generation in quality system to monitor and reconcile archived records in QMS and the GMP Library.
- Executed Paper-based Controlled Print Requests on request to facilitate all GMP activities at Lilly Limerick while the digital solutions are being implemented.
- Ensured compliance supporting GXP processes by ensuring the proper management of physical records while adhering to Lilly's global standards, the process aims to guarantee compliance and efficiency in record management.
- Manage the flow of document workflows from creation, initiation, review, and approval.
- Liaised cross functionally to set up off-site Archive and storage of records can be utilized to facilitate the retention of record that are not expected to be referred to on a regular basis but must be retained to ensure compliance with the global records retention policy.
Technical Writer/Compliance Specialist (Consultant) - Regeneron Pharmaceuticals - Raheen, County Limerick
(2018-11 - 2024-09)
Technical Writer within the Automation/Engineering - IOPS Technical Operations department, predominantly working on the PER (Periodic Evaluation Report) program.
- Ensure Quality Compliance across all Engineering & Automation activities at Regeneron.
- Maintain up-to-date knowledge of current Good Manufacturing Practices (GMPs) through completion of relevant SOPs (Standard Operating Procedures) and CBTs (Computer-Based Training) to support daily operations.
- Perform periodic reviews, including Periodic Evaluation Reports (PERs), involving the generation and maintenance of technical documentation in alignment with current templates, work instructions, and applicable SOPs. Manage the PER lifecycle within the Electronic Document Management System (EDMS), including workflow initiation, revision, routing, approval, and final release.
- Collaborate with Subject Matter Experts (SMEs) and cross-functional stakeholders to ensure the accuracy, completeness, and timely delivery of PERs and associated technical documentation.
- Coordinate cross-functional review activities (Automation/Engineering, Manufacturing, Validation, and Quality Assurance), facilitating "Please Review" (PR) workflows to gather and incorporate feedback.
