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:
- Implement and manage an Electronic Document Management System (EDMS).
- Issue and control batch records, logbooks, and SOPs for production.
- Manage qualification documents for Engineering/Validation teams.
- Oversee 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, QMS, and Training departments.
- Conduct GMP process audits and assist during regulatory inspections.
Requirements:
- Level 5 qualification (minimum).
- 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 is a fantastic opportunity to join a leading pharmaceutical company in Cashel and play a key role in ensuring documentation meets regulatory and quality standard
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