QA Validation Specialist
Work in an organisation that supports its staff and focuses on staff experience as much as it does the experience of its patients? You can live and breathe in an area that has the cleanest air, cost effective living, great nightlife, some of the best schools with a wealth of history available on your doorstep.
Sound too good to be true? Well it isn’t, this is what you get when you work for Northumbria Healthcare and, this is…the Northumbria Way!
What the Northumbria Way means for you:
- Extensive staff health and well-being programme including access to our specialist Wellbeing Hub
- Support and connection through a variety of Staff Network groups
- A range of flexible working opportunities
- Generous annual leave and pension scheme
- Access to lease car and home electronics scheme (qualifying criteria applies)
- Opportunities to improve your professional development through our vast training programmes
- On-site nursery places via salary sacrifice
- Access to savings scheme via salary sacrifice with Northumberland Community Bank
Our teams deliver care from hospitals, a range of community venues and people’s homes. Our hospitals include a specialist emergency care hospital (the first of its kind in England), three general hospitals and community hospitals. In the community we deliver a wide range of community and public health services.
We lead in innovation and quality, having opened the Northumbria Healthcare Manufacturing and Innovation Hub during the Covid-19 pandemic and have recently launched our Community Promise – a pledge to make a real impact not just in healthcare but on the wider factors that affect people’s lives, such as education, employment and the economy.
If Northumbria Healthcare sounds like somewhere you could belong we would love to hear from you. Visit our website to catch up on our latest news.
Whilst Northumbria Healthcare are a highly innovative organisation, the use of Third Party Artificial Intelligence (AI) presents a risk to the integrity of our Recruitment & Selection processes. If you use AI, and it poses a risk to the integrity your individual recruitment process, we may withdraw your application at any stage of the process.
Job overview
An exciting opportunity has arisen for a QA Validation Specialist to play a key role in ensuring compliance with EU GMP at the Medicines Manufacturing Centre (MMC). Based in Seaton Delaval, Northumberland, the MMC is a state-of-the-art NHS facility dedicated to the sterile manufacture of injectable medicinal products.
Operating under MHRA Good Manufacturing Practice (GMP) standards, the MMC ensures a secure supply chain for Systemic Anti-Cancer Therapy (SACT) products, while delivering Ready-to-Administer (RtA) medicines to enable nurses to spend more time on patient care.
As a QA Validation Specialist, you will be responsible for managing all validation activities, ensuring equipment, processes, and systems comply with regulatory requirements and best practices.
Working at MMC
The MMC is in its final design stages, with facility construction planned through to September 2025. Initially, staff will be employed by Northumbria Healthcare Foundation NHS Trust, with employment transferring to the Medicines Manufacturing Centre Legal Liability Partnership (LLP) upon its formation under TUPE regulations.
This is a unique opportunity to be part of a pioneering NHS facility, ensuring that MMC becomes a leader in aseptic manufacturing, validation, and regulatory compliance. If you are passionate about quality assurance, validation, and making a difference in patient care, we would love to hear from you.
Main duties of the job
What You’ll Be Doing
You will be responsible for maintaining validation systems and quality assurance processes, ensuring compliance with EU GMP and regulatory requirements.
Key Responsibilities:
- Develop and manage the Validation Master Plan (VMP) and oversee new equipment introduction, validation, and revalidation.
- Lead Quality Risk Management (QRM) activities for process design, ensuring Critical Process Parameters (CPP) and Critical Quality Attributes (CQA) are effectively managed.
- Provide QA oversight of Process Validations, including Aseptic Process Simulation (APS), operator validation, gowning validation, and cleaning validation.
- Manage outsourced activity, including supplier approval, Quality Technical Agreements, and contractor oversight.
- Oversee the Contamination Control Strategy (CCS) and environmental monitoring program in collaboration with the Site Microbiologist.
- Support QA capacity planning and oversee unit crisis management procedures and site shutdown planning.
- Deliver QA system training across MMC to ensure compliance and staff competency.
- Promote continuous improvement and innovation to enhance quality, compliance, and operational efficiency.
Working for our organisation
We manage three major locality hospitals at North Tyneside, Wansbeck and Hexham, plus a number of smaller community hospitals and clinics from Tynemouth to Berwick on Tweed, in addition to our state-of-the-art Northumbria Specialist Emergency Care Hospital, the first of its kind in England.We also care for people in their homes and provide services from facilities in local communities such as health centres. We give people greater choice and control over their care to help them to live independently at home and avoid hospital admission where appropriate.
High quality patient care is at the heart of everything we do and we strive to ensure every single patient and service user has an exceptional experience with us. We have one of the most extensive patient experience programmes of any trust in England.
Detailed job description and main responsibilities
To support and maintain all validation activities within the MMC to ensure they are all carried out in compliance with EU GMP.
To introduce and manage core Pharmaceutical Quality Systems (PQS) in relation to equipment management i.e. Validation Master Plan (VMP), New equipment introduction processes, equipment validation, revalidation, repairs, planned preventative maintenance (PPM), Permit to work (PTW).
To provide Outsourced Activity management of contractors e.g. supplier approval of contractors, Quality Technical Agreements, Monitoring of outsourced activity reporting system and supplier review.
To introduce and manage core Pharmaceutical Quality Systems (PQS) in relation to New Product Introduction and act as the Quality Risk Management (QRM) lead for process design e.g. Critical Process Parameters (CPP) / Critical Quality Attributes (CQA) and Product Quality Reviews (PQR).
Person specification
Qualifications
Essential criteria- Degree in relevant scientific discipline or relevant experience.Or Basic qualification in pharmaceutical sciences (BTEC) or an equivalent scientific qualification to same level with a Postgraduate Diploma in Pharmaceutical Technology or similar.
- Eligible to be Registered Professional with the General Pharmaceutical Council (GPhC), Health and Care Professions Council HCPC, Royal Society for Chemistry (RSC) or Royal Society for Biology (RSB), or Royal Pharmaceutical Society (RPS)
- Management qualification
- Professional Registration
Experience
Essential criteria- Post qualification experience in Pharmaceutical Manufacturing, Pharmaceutical Quality Control or Quality Assurance.
- Experience of Quality Risk Management (QRM)
- Experience in the management and maintenance of pharmaceutical quality systems. Such as: Deviations, Change Control, Root Cause Analysis, CAPA, Quality Risk Management, Complaints, Recall, Supplier approval and management of outsourced activity.
- Experience of New Production Introduction management
- Experience in manufacture of sterile medicines
- Knowledge of or experience in coaching and mentoring practices and tools
- Knowledge of or experience in Quality improvement tools, techniques and methods.
Applicants who are members of the Armed Forces, and those who have a disability that requires support in the work place (two ticks pledge) and who meet the essential criteria will be interviewed under the Trust's interview guarantee scheme.
We recognise the positive value of diversity and inclusion and are committed to a workforce that is diverse, equal and inclusive. We welcome and encourage job applications from people of all backgrounds. We particularly welcome applications from Black, Asian and Minority Ethnic (BAME) candidates as BAME people are currently under-represented in our workforce as well as other under-represented groups such as LGBT+ and disabled candidates.We are proud to be a Disability Confident Employer, a Stonewall Diversity Champion, we have a Gold award from the Defense Recognition Scheme, and we are delighted to support Apprenticeships, Age Posi+ive and are a mindful employer.
If you require any reasonable adjustments to attend interview please make the recruitment team aware as soon as possible by calling our HR Recruitment Team on 0191 203 1415 option 2.
Applicants who meet the Fit and Proper Person Requirements (FPPR) will require additional pre-employment checks in line with CQC and NHS England statutory guidance.
Make sure to read the ‘applicant guidance notes’ before submitting your application and make sure you know everything there is to know before joining our fantastic trust!
Certificate of Sponsorship
Northumbria Healthcare NHS Foundation Trust proudly hold a sponsor licence. In order to provide sponsorship you and the role you are applying for must meet UKVI eligibility requirements. Please check your eligibility prior to submitting an application.Skilled Worker visa: Overview - GOV.UK (www.gov.uk)
Please note that it is a requirement of this Trust that all successful applicants pay for their own DBS certification if a DBS check is required for the post. The method of payment is a salary deduction from your first monthly pay.