Document Controller

Cardiff and Vale University Health Board; Seaton Delaval; On-site; GBP 21,000 - 32,000; Full time

Job summary

The Medicines Manufacturing Centre (MMC) is a brand-new NHS pharmaceutical production facility located at the Northumbria Innovation and Manufacturing Hub in Seaton Delaval, Northumberland. It operates under MHRA, GMP, and GDP standards and aims to supply Ready-to-Administer medicines with regional impact.

This role provides QA administration to support compliance, document management, and training material updates.

Qualifications

• NVQ Level 3 Science Manufacturing Technician or equivalent qualification.
• Knowledge of organisational policies and procedures and experience with non-routine issues.
• Experience working in a regulated environment.
• Coaching and mentoring practices and tools knowledge.
• Knowledge of quality improvement tools and methods.
• Experience performing audits and recording findings.

Responsibilities

• Contribute to GMP-compliant manufacturing facility delivery to optimise regional benefit.
• Support QA activities for products and processes under the MMC's MS Licence, ensuring MHRA/NHS standards compliance.
• Provide administrative QA resource to support GMP compliance at the MMC and manage the eQMS document management module.
• Manage document storage, archiving, and paper/hybrid document workflows with training forms and validation protocols.
• Collaborate with the QA Computerised Systems Validator to execute validation protocols and address data integrity issues.
• Set up and maintain the Asset, Supplier and Audit modules on the eQMS, updating records and supporting related processes.
• Support PQS modules (CAPA, I&O) and assist with training material updates and complaints handling.

Skills

Regulated environment experience

Similar roles experience

Coaching & mentoring

Quality improvement tools

Audits & findings

Education

NVQ Level 3 Science Manufacturing Technician or equivalent

Job description

Responsibilities

• To contribute to the delivery of a GMP compliant manufacturing facility that optimises theregional benefit from the £30 million funding provided by NHSE.
• Support QA activities for products and processes under the MMC's MS Licence, ensuring thecompliance with MHRA and NHS standards.
• Provides administrative QA resource to support GMP compliance at the MMC, Manage and maintain the electronic Quality Management System (eQMS) documentmanagement module, including document issuance, compatibility checks, templatecreation/maintenance, controlled copy management (issuance and reconciliation), andoversight of any paper or hybrid processes (e.g., wet signatures, scanned uploads, periodicreviews).
• Manage document storage and archiving processes, including oversight of the DocumentRecords Store and maintenance of hard copy documents e.g. training forms, validationprotocols etc. ensuring compliance, traceability and accessibility.
• Collaborate with the QA Computerised Systems Validator to execute system validationprotocols and elevate/document any data integrity or document-management-relatedadministrative issues.
• Set up and maintain the Asset Module on the eQMS, including data entry, record updates andsupporting the QA Validation team to track asset related-requirements
• Set up and maintain the Supplier module on the eQMS, including data entry, record updates,and supporting supplier approval processes by liaising with suppliers to obtain requiredqualification documentation.
• Set up and maintain the Audit module on the eQMS, including data entry, supporting the QAOperations team with audit scheduling, documentation, and tracking of findings.
• Provide administrative support across additional PQS modules, including CAPA (Correctiveand Preventive Actions) and Incidents & Occurrence (I&O), ensuring accurate data entry,tracking of actions, and timely follow-up.
• Support the development and updating of training materials related to PQS processes,including assistance with procedure updates and controlled document revisions.
• Assist with complaints management activities, including drafting correspondence, supportingsupplier communications, and maintaining accurate complaint records.
• Support Quality Key Performance Indicator (KPI) tracking and reporting, assisting in thepreparation of metric reports and ensuring accurate and timely performance data for QAreview., You may also need to travel between Trust premises as required for the performance of your duties. You may also be expected to work at any of the trust sites. The Trust would consider making reasonable adjustments to the role, if necessary, to enable a disabled person to undertake the role.

Requirements

• NVQ Level 3 Science Manufacturing Technician or equivalent qualification, Knowledge of organisational policies and procedures and experience of dealing with non-routine issues
• Experience of working in a regulated environment., Previous experience in similar roles
• Knowledge of or experience in coaching and mentoring practices and tools
• Knowledge of or experience in Quality improvement tools, techniques and methods
• Experience of performing audits and recording findings

About the MMC

The Medicines Manufacturing Centre (MMC) is a brand-new, purpose-built NHS pharmaceutical production facility located at the Northumbria Innovation and Manufacturing Hub in Seaton Delaval, Northumberland. This cutting-edge centre is part of the North East and North Cumbria Provider Collaborative and has been established to meet the growing need for high-quality, regionally manufactured Ready-to-Administer (RtA) medicines and advanced aseptic products. Funded with £30 million of investment from NHS England, the MMC will support a secure, sustainable supply chain for critical medicines, particularly for oncology and other high-risk therapies, while creating skilled jobs and driving innovation across the region. The facility is designed to operate under a Manufacturer's Specials Licence (MS) and aims to secure a Wholesale Dealer's Authorisation (WDA(H)), ensuring compliance with MHRA, GMP, and GDP regulations from day one. At the MMC, quality, patient safety, and staff wellbeing are at the heart of everything we do. Our leadership team is committed to building a culture of openness, learning, and continuous improvement--offering staff a rare opportunity to help shape the systems, teams, and values of a truly modern NHS manufacturing unit. Working at the MMC means being part of a forward-thinking and supportive team focused on enabling frontline clinical staff to spend more time with patients by delivering safe, ready-to-use medicines.