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Senior Document Controller
Northumbria Healthcare NHS Foundation Trust View all jobs
Posted 1 month(s) ago
Reference: 319-8258891JN
Job summary
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 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
About us
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.
Details
Date posted
03 September 2026
Pay scheme
Agenda for change
Band
Band 4
Salary
£28,392 to £31,157 a year per annum
Contract
Permanent
Working pattern
Full-time, Flexible working, Compressed hours
Reference number
319-8258891JN
Job locations
Northumbria Healthcare Manufacturing and Innovation Hub
Avenue Road
Seaton Delaval
NE25 0QJ
United Kingdom
Job description
Job responsibilities
- 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.
Job description
Job responsibilities
- 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.
Person Specification
Qualifications
Essential
- NVQ Level 3 Science Manufacturing Technician or equivalent qualification
Experience and knowledge
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
Other requirements
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.
Person Specification
Qualifications
Essential
- NVQ Level 3 Science Manufacturing Technician or equivalent qualification
Experience and knowledge
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
Other requirements
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.
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Certificate of Sponsorship
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Certificate of Sponsorship
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Employer details
Employer name
Northumbria Healthcare NHS Foundation Trust
Address
Northumbria Healthcare Manufacturing and Innovation Hub
Avenue Road
Seaton Delaval
NE25 0QJ
United Kingdom
Employer's website
https://www.northumbria.nhs.uk/ (Opens in a new tab)
Employer details
Employer name
Northumbria Healthcare NHS Foundation Trust
Address
Northumbria Healthcare Manufacturing and Innovation Hub
Avenue Road
Seaton Delaval
NE25 0QJ
United Kingdom
Employer's website
https://www.northumbria.nhs.uk/ (Opens in a new tab)