Senior Document Controller

Job overview

An exciting opportunity has arisen for a proactive and passionate Senior Document Controller to join the Medicines Manufacturing Centre (MMC)—a cutting-edge NHS pharmaceutical production facility based in Seaton Delaval, Northumberland. The MMC is in its final design stages. This is a fantastic opportunity to be part of a pioneering NHS manufacturing facility, supporting a leadership team committed to quality, innovation, and patient care. Please note we reserve the right to close this vacancy prior to the closing date once the required number of suitable applications have been received.

All employees of the Medicine Manufacturing Centre (MMC) are currently employed by Northumbria Healthcare NHS Foundation Trust, under Agenda for Change Terms and Conditions. Should the service be transferred into alternative ownership, those employees with start dates prior to the transfer date, will be protected under Transfer of Undertakings (Protection of Employment) Regulations 2006 (TUPE). Therefore, employees will transfer to the new employer on the same terms and conditions, which are protected and the employees’ continuity of employment is preserved

Main duties of the job

• To contribute to the delivery of a GMP compliant manufacturing facility that optimises the regional benefit from the £30 million funding provided by NHSE.
• Support QA activities for products and processes under the MMC’s MS Licence, ensuring the compliance with MHRA and NHS standards.
• Provides administrative QA resource to support GMP compliance at the MMC

Detailed job description and main responsibilities

• Manage and maintain the electronic Quality Management System (eQMS) document management module, including document issuance, compatibility checks, template creation/maintenance, controlled copy management (issuance and reconciliation), and oversight of any paper or hybrid processes (e.g., wet signatures, scanned uploads, periodic reviews).
• Manage document storage and archiving processes, including oversight of the Document Records Store and maintenance of hard copy documents e.g. training forms, validation protocols etc. ensuring compliance, traceability and accessibility.
• Collaborate with the QA Computerised Systems Validator to execute system validation protocols and escalate/document any data integrity or document-management-related administrative issues.
• Set up and maintain the Asset Module on the eQMS, including data entry, record updates and supporting 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 required qualification documentation.
• Set up and maintain the Audit module on the eQMS, including data entry, supporting the QA Operations team with audit scheduling, documentation, and tracking of findings.
• Provide administrative support across additional PQS modules, including CAPA (Corrective and 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, supporting supplier communications, and maintaining accurate complaint records.
• Support Quality Key Performance Indicator (KPI) tracking and reporting, assisting in the preparation of metric reports and ensuring accurate and timely performance data for QA review.