Document Controller

2 weeks ago

Tralee, Ireland Fastnet Full time

QA Document Control Specialist – (Contract, Hybrid)We are partnering with a leading pharmaceutical company on a fantastic opportunity for a QA Document Control Specialist.Role OverviewYou will ensure all GMP-controlled documents meet site and regulatory standards in terms of formatting, layout, numbering, and metadata, rather than content.The role involves working across multiple systems, including EDMS (Veeva Vault or similar), ValGenesis, and RMS, and collaborating closely with the Learning & Development team to ensure training materials and documents meet technical standards.Key ResponsibilitiesReview and approve controlled documents across EDMS (Veeva Vault or similar), ValGenesis, and RMS for formatting, numbering, and metadata compliance.Ensure adherence to site standards for page layout, fonts, headers/footers, numbering, and other formatting conventions.Support change control (DCC) processes by verifying technical document attributes during revisions.Validate document metadata (author, version, effective date, approvals) for accuracy and completeness.Perform controlled print issuance, indexing, and archiving of documents in accordance with cGMP standards.Collaborate with authors, reviewers, approvers, and the Learning & Development team to ensure consistency across training and operational documents.Participate in internal and external audits/inspections, providing evidence of document compliance and technical integrity.Identify and implement opportunities to improve document control processes and system integration.Required QualificationsBachelor's degree in a scientific or technical discipline.2+ years' experience in QA Document Control or a related quality function in a regulated environment.Experience with EDMS (Veeva Vault or similar) and familiarity with ValGenesis and RMS.Strong knowledge of GxP regulations, FDA/ICH guidance, and GMP best practices.Detail-oriented, organized, and able to manage multiple priorities under deadlines.Preferred QualificationsFamiliarity with document metadata management and technical formatting standards in GMP environments.Prior experience supporting audits and inspections in a QA document control capacity.This is an exciting opportunity to join a new manufacturing plant being established.As a QA Document Control Specialist, you will play a critical role in setting up and maintaining document standards and compliance processes from the ground up, ensuring that GMP-controlled documents are properly formatted, numbered, and accurately tracked across multiple systems (EDMS, ValGenesis, RMS).

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