Document Controller

2 weeks ago

Cashel, Ireland Cpl Full time
Document Controller – Pharmaceutical (GMP) – Cashel

Our pharma client based in Cashel is looking for a Document Controller to join their team. This role involves managing and controlling GMP documentation to support production, quality, and compliance activities.

Key Responsibilities:
  1. Implement and manage an Electronic Document Management System (EDMS).
  2. Issue and control batch records, logbooks, and SOPs for production.
  3. Manage qualification documents for Engineering/Validation teams.
  4. Oversee QC/ARD specifications, protocols, and artwork documentation.
  5. Ensure proper archiving and storage of documents.
  6. Prepare and update SOPs, reports, and forms as needed.
  7. Lead investigations related to document control.
  8. Support Quality Management, QMS, and Training departments.
  9. Conduct GMP process audits and assist during regulatory inspections.
Requirements:
  1. Level 5 qualification (minimum).
  2. 3+ years of experience in document control within a pharmaceutical GMP environment.
  3. Hands-on experience with Electronic Document Management Systems (EDMS).
  4. Strong knowledge of GMP compliance and regulatory documentation.

This is a fantastic opportunity to join a leading pharmaceutical company in Cashel and play a key role in ensuring documentation meets regulatory and quality standards.

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