Job summary
An exciting opportunity has arisen for a highly organised and proactive Quality Assurance Officer 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, 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 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.
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 technical QA resource, advice, and support to ensure GMP compliance at the MMC.
- Responsible for managing and training Quality Assurance staff.
- Manages the team that assures the quality of and release unlicensed medicines to the value of approximately £20 million per annum.
About us
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.
Job description
Job responsibilities
- To support and maintain the Pharmaceutical Quality System (PQS) within theMedicines Manufacturing Centre (MMC), ensuring compliance with Good Manufacturing Practice (GMP), NHS guidance, and MHRA regulations.
- To complete relevant aspects of the PQS reporting systems e.g. Documentation Control, revision and approval, Change Control, Deviations, Quality RiskAssessments, Root Cause Analysis, Micro non-conformances, Complaints, Supplier Approval, Key Performance Indicator Trending, Quality Technical Agreements and Training Processes.
- To co-ordinate and perform the review, approval, and monitoring of QA processes, documentation, and release of products, as well as ensuring continuous improvement and regulatory compliance.
- To participate on investigations involving the quality of pharmaceutical products across the MMC
- To manage the Quality Assurance staff during day-to-day operations and longer-term planning
- To plan and implement a strategy to ensure a robust and fit for purpose Quality Assurance workforce throughout the product lifecycle
- To develop and monitor quality KPIs which demonstrate the state of control of the facility, and report these to the senior management team
- To role model compassionate and inclusive leadership to shape the creation of a collective leadership culture within the Trust. This means demonstrating a consistent leadership style which (a) engages, enables and empowers others (b) uses coaching to promote ownership of learning and quality improvement and (c)facilitates team working and collaboration within teams / departments and across organisational boundaries.
Job description
Job responsibilities
- To support and maintain the Pharmaceutical Quality System (PQS) within theMedicines Manufacturing Centre (MMC), ensuring compliance with Good Manufacturing Practice (GMP), NHS guidance, and MHRA regulations.
- To complete relevant aspects of the PQS reporting systems e.g. Documentation Control, revision and approval, Change Control, Deviations, Quality RiskAssessments, Root Cause Analysis, Micro non-conformances, Complaints, Supplier Approval, Key Performance Indicator Trending, Quality Technical Agreements and Training Processes.
- To co-ordinate and perform the review, approval, and monitoring of QA processes, documentation, and release of products, as well as ensuring continuous improvement and regulatory compliance.
- To participate on investigations involving the quality of pharmaceutical products across the MMC
- To manage the Quality Assurance staff during day-to-day operations and longer-term planning
- To plan and implement a strategy to ensure a robust and fit for purpose Quality Assurance workforce throughout the product lifecycle
- To develop and monitor quality KPIs which demonstrate the state of control of the facility, and report these to the senior management team
- To role model compassionate and inclusive leadership to shape the creation of a collective leadership culture within the Trust. This means demonstrating a consistent leadership style which (a) engages, enables and empowers others (b) uses coaching to promote ownership of learning and quality improvement and (c)facilitates team working and collaboration within teams / departments and across organisational boundaries.
Person Specification
Qualifications / Professional Registration
Essential
- Degree in Pharmacy, Chemistry, Biology, or a related scientific field or equivalent 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 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).
Desirable
- Master Qualification in a scientific discipline (preferably in Pharmaceutical Manufacture) or be willing to work towards a Diploma / Master's degree while in post.
- Management qualification
- Professional Registration
Experience and knowledge
Essential
- Knowledge of GMP and MHRA guidelines and experience of working in a regulated environment.
- Significant experience postqualification relevant GMP experience.
- Extensive experience in the management and maintenance of pharmaceutical quality systems.
- Evidence of continuing education/professional CPD
Desirable
- Evidence of managing product release.
- Evidence of successfully managing a team
- Experience in manufacture of sterile medicines
- Experience of training colleagues in GMP
- Knowledge of or experience in coaching and mentoring practices and tools
- Knowledge of or experience in Quality improvement tools, techniques and methods.
Person Specification
Qualifications / Professional Registration
Essential
- Degree in Pharmacy, Chemistry, Biology, or a related scientific field or equivalent 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 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).
Desirable
- Master Qualification in a scientific discipline (preferably in Pharmaceutical Manufacture) or be willing to work towards a Diploma / Master's degree while in post.
- Management qualification
- Professional Registration
Experience and knowledge
Essential
- Knowledge of GMP and MHRA guidelines and experience of working in a regulated environment.
- Significant experience postqualification relevant GMP experience.
- Extensive experience in the management and maintenance of pharmaceutical quality systems.
- Evidence of continuing education/professional CPD
Desirable
- Evidence of managing product release.
- Evidence of successfully managing a team
- Experience in manufacture of sterile medicines
- Experience of training colleagues in GMP
- Knowledge of or experience in coaching and mentoring practices and tools
- Knowledge of or experience in Quality improvement tools, techniques and methods.
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.
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.
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).
