Senior Document Controller

• 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 escalate/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.

Essential

• NVQ Level 3 Science Manufacturing Technician or equivalent qualification

Essential

• Knowledge of organisational policies and procedures and experience of dealing with non-routine issues
• Experience of working in a regulated environment.

Desirable

• 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

Desirable

• 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.