QA Document Controller

Job Overview

QA Document Controller

Permanent employee, Full-time · Shannon

YOUR MISSION

To provide Document Control support for the Irish manufacturing site during facility design, build and routine operations thereafter.

The Document Controller will work closely with the Irish project team and play a key role in providing hands on and "boots on the ground" support and control of documents generated as part of the project.

JOB DESCRIPTION
Major Activities
  • Establish and maintain a Document control system covering the document lifecycle from generation to obsoleting for documents generated as part of the project for documents controlled via eQMS, MasterControl or via a paper-based system.
  • Provide Document Control support to the Irish project team ensuring that all documents generated are managed, maintained, stored and archived in compliance with EU, Irish and FDA cGMP regulatory requirements and QMS.
  • Setup a document management system for documentation generated and controlled outside MasterControl, ensuring documents are maintained in an easily retrievable state.
  • Perform daily administrative tasks including, but not limited to:
Document Issuance, Review, Approval, Release, archiving and retention.
Monitoring and tracking of document progression through lifecycle steps.
Provide training within own area of responsibility.

  • Author and maintain procedural documents related to management of documents within the QMS.
  • Update and maintaining site training curriculum linked to procedures within the QMS.
  • Provide Key Performance Indicator Reports for departments as required.
  • Support the Quality Assurance team in issue and change control management where requested.
  • Support the Quality Assurance team in other activities where requested.
  • Support Customer Audit and Regulatory Inspections.
  • Ensure own work complies with GMP, Data integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable quality documents e.g. SOP's.
  • Ensure own training in undertaken in a timely and GMP compliant manner before the task is undertaken.
  • Ensure own KPI's, plans, targets and objectives are effectively tracked, monitored and achieved in accordance with timelines.
  • Can deputise for Document Controllers within the MeiraGTx network.

Key Performance Indicators
  • Document control system is maintained in a compliant state.
  • Administrative tasks are completed contemporaneously e.g. users are provided with access when applicable, documents are reviewed and approved in a timely manner to facilitate the progression of GxP activities.
  • Documentation maintained outside of the MasterControl system is maintained in a controlled but an easily retrievable state.
  • Any records overdue are escalated appropriately to facilitate progression.
  • Metrics Reports are accurate and provided in a contemporaneous manner as required.

Key Job Competencies
  • Experience in working with electronic and paper based GMP Quality Management Systems for document and process management.
  • Fully computer literate, proficient with standard software packages on an advanced level (such as Microsoft applications, specifically Excel, Word, PowerPoint) and adaptable to new software packages / web applications.
  • Experience in developing and delivering end user training, preferred system training.
  • Excellent interpersonal skills.
  • Good organisational and time management skills and able to demonstrate flexibility and adaptability.
  • Experience working with high volumes of documentation, electronic and paper.
  • Good attention to detail for data entry tasks and understanding of Good Documentation Practices.
  • Experience and knowledge of working in a GMP regulated environment, specifically with regards to record retention.

Job Background
  • Minimum of 3 years experience working in a GxP environment.
  • IT literate, experience managing and operating an electronic QMS.
  • English language required.

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