Main area Medicines Manufacturing Centre - Research and Development Grade NHS AfC: Band 7 Contract Permanent Hours
* Full time
* Flexible working
* Compressed hours
37.5 hours per week Job ref 319-7032048JN
Site Manufacturing and Innovation Hub Town Seaton Delaval Salary £46,148 - £52,809 per annum Salary period Yearly Closing 28/04/2025 23:59
Do you want to work in one of the best performing NHS organisations in England? Work for an organisation that was voted the best acute and combined acute and community trust in the country, based on the experience of its staff (NHS Staff Survey 2022). 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
We are proud to be one of the country’s top performing NHS trusts – rated ‘outstanding’ overall by the Care Quality Commission (CQC). We provide a range of health and care services to support more than 500,000 people living in Northumberland and North Tyneside across the largest geographical area of any NHS Trust in England. 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.
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.
Person specification
Qualifications
* Degree in relevant scientific discipline or relevant experience.
* 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)
* Professional Registration
Experience
* 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.
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