Document Controller – Pharmaceutical (GMP)
The role of a Document Controller is crucial in maintaining accurate and up-to-date documentation within a pharmaceutical GMP environment.
Main Responsibilities:
* Implement and manage an Electronic Document Management System (EDMS).
* Issue and control batch records, logbooks, and Standard Operating Procedures (SOPs) for production.
* Manage qualification documents for Engineering/Validation teams.
* Oversee Quality Control/Automatic Release Department (QC/ARD) specifications, protocols, and artwork documentation.
* Ensure proper archiving and storage of documents.
* Prepare and update SOPs, reports, and forms as needed.
* Lead investigations related to document control.
* Support Quality Management, Quality Management System (QMS), and Training departments.
* Conduct Good Manufacturing Practice (GMP) process audits and assist during regulatory inspections.
Requirements:
* A minimum Level 5 qualification.
* At least 3 years of experience in document control within a pharmaceutical GMP environment.
* Hands-on experience with Electronic Document Management Systems (EDMS).
* Strong knowledge of GMP compliance and regulatory documentation.
This position presents a unique opportunity to work for a leading pharmaceutical company in Cashel and contribute to the development of a robust documentation framework that meets regulatory and quality standards.