Job summary
Ready to take your pharmacy career to the next level? Join our expert team at St Mary's Pharmaceutical Unit (SMPU) a leading NHS manufacturing facility delivering specialist medicines across Wales & beyond. This is your chance to work at the forefront of aseptic services, clinical trials and licensed production, making a real impact on patient care and research.
We are seeking an experienced Band 8a Aseptic / Clinical Trials Pharmacist to take a key leadership role.
You will:
Deputise for the Accountable Pharmacist for Section 10 activities, ensuring MHRA & GMP compliance.
Release aseptic products, safeguarding quality and patient safety.
Support clinical trials under Section 37.
Engage in MS licensed production, broadening regulatory expertise.
Collaborate with a multidisciplinary team to deliver services.
We're Looking For:
A qualified pharmacist with experience in aseptic services, clinical trials or licensed manufacturing.
Strong knowledge of GMP, MHRA requirements & quality systems.
Excellent leadership, communication and problem-solving skills.
A proactive, detail-oriented approach with a drive to advancepharmacy practice.
Why SMPU?
Be part of a specialist NHS unit with a reputation for excellence.
Work on groundbreaking clinical trials shaping future care.
Gain exposure to licensed production & expand regulatory knowledge.
Enjoy professional development, flexible working & NHS benefits.
Apply now & help deliver life-changing therapies while supporting vital research.
Main duties of the job
To deputise for the Head of Production / Aseptic Services ensuring safe and compliant Pharmacy Technical Services are maintained, evaluating and prioritising services when constraints occur, and liaising and negotiating with internal and external stakeholders to maximise production.
To lead a team developing new products and processes using Quality Risk Management (QRM) and Quality by Design (QBD) principles to grow existing services and to widen the scope in line with emerging therapies such as Advanced Therapy Medicinal Products.
To create, monitor and review the Capacity and Contingency Plans for Aseptic / Production and Clinical Trial Services
To regularly undertake research, creating evidence to support service development and enable the evaluation of services across the manufacturing unit.
To work closely with the wider pharmacy clinical trials team, demonstrating senior leadership for this area especially where there is collaboration required between the teams.
To participate in product approval of Section 10 products and the release of Manufacturing Specials products.
About us
Cardiff and Vale University Health Board is one of the largest Integrated Health Boards in the UK, employing over 17,000 staff, providing over 100 specialist services. Working across 6 hospital sites, we have a diverse range of career opportunities to offer. Serving over 500,000 people living in Cardiff and the Vale, we are focussed on the health and care needs of our local population whilst working with our partners to develop regional services. Together we are committed to improving health outcomes for everyone, delivering excellent care and support.
Our mission is "Living Well, Caring Well, Working Together", and our vision is that every person's chance of leading a healthy life should be equal. Our 10-year transformation and improvement strategy, Shaping Our Future Wellbeing, is our chance to work collaboratively with the public and our workforce to make our health board more sustainable for the future.
Job description
Job responsibilities
You will be able to find a full Job description and Person Specification attached within the supporting documents or please click Apply now to view in Trac
To plan, implement, maintain and evaluate clinical production activities including staff, resources, activity, processes, and information, ensuring the highest level of professional standards of service are provided, encompassing both quality and timeliness of service to patients.
To manage the overall workload in accordance with the capacity plan ensuring staff rotas reflect an appropriate skill mix for the allocated tasks and are an effective use of staff time, prioritising and adjusting plans as required.
To be responsible for ensuring all equipment is validated and functioning correctly, and all plant and equipment planned preventative and corrective maintenance is carried out.
To manage the environmental monitoring processes in line with current guidance and to ensure correct action is taken in the event of a deviation. This will include liaising with the Quality Assurance team where appropriate to resolve any validation or monitoring issues.
To develop distribution systems and processes under controlled conditions.
To ensure that all staff adhere to hygiene and clothing policies associated with their work within the controlled cleanroom environment. This involves strict hand washing procedures and changing into designated cleanroom clothing.
To ensure the digital systems are fit for purpose and approve accuracy of master process and procedure documentation.
To contribute to the update and maintenance of the Site Master File in collaboration with the Production Manager and Quality Assurance Lead, analysing data from several sources and presenting findings for internal use and publication, when required.
To be responsible for the handling of Controlled drugs in accordance with professional, ethical and legal guidelines.
Job description
Job responsibilities
You will be able to find a full Job description and Person Specification attached within the supporting documents or please click Apply now to view in Trac
To plan, implement, maintain and evaluate clinical production activities including staff, resources, activity, processes, and information, ensuring the highest level of professional standards of service are provided, encompassing both quality and timeliness of service to patients.
To manage the overall workload in accordance with the capacity plan ensuring staff rotas reflect an appropriate skill mix for the allocated tasks and are an effective use of staff time, prioritising and adjusting plans as required.
To be responsible for ensuring all equipment is validated and functioning correctly, and all plant and equipment planned preventative and corrective maintenance is carried out.
To manage the environmental monitoring processes in line with current guidance and to ensure correct action is taken in the event of a deviation. This will include liaising with the Quality Assurance team where appropriate to resolve any validation or monitoring issues.
To develop distribution systems and processes under controlled conditions.
To ensure that all staff adhere to hygiene and clothing policies associated with their work within the controlled cleanroom environment. This involves strict hand washing procedures and changing into designated cleanroom clothing.
To ensure the digital systems are fit for purpose and approve accuracy of master process and procedure documentation.
To contribute to the update and maintenance of the Site Master File in collaboration with the Production Manager and Quality Assurance Lead, analysing data from several sources and presenting findings for internal use and publication, when required.
To be responsible for the handling of Controlled drugs in accordance with professional, ethical and legal guidelines.
Person Specification
Qualifications & Knowledge
Essential
- Master's degree such as Level 7 Pharmaceutical Technology & Quality Assurance (PTQA) (Masters) or Scientist Training Programme (STP) Pharmaceutical Science or relevant pharmaceutical knowledge, and specialist and practical experience of GMP systems management acquired over five years (as defined by MHRA guidance) and equivalent to that required for a post-graduate diploma.
- Management or Leadership qualification or accreditation - or demonstrable equivalent experience.
- Registered with the General Pharmaceutical Council or other relevant professional body.
Desirable
- Accredited Product Approver (S10 Medical Act) and Cleanroom Supervision (CRS) accreditation (or be able to undertake)
- Quality Improvement Accreditation
- Training qualification or accreditation, or equivalent experience
Experience
Essential
- Relevant post-qualification GMP experience providing NHS Aseptic services or within an MHRA licensed unit
- Experience of Quality Risk Management (QRM) or other comprehensive pharmaceutical quality management system
- Experience of undertaking risk assessment, root cause analysis and CAPA, change control
- Experience of stock management of hazardous and time-limited materials, and interpretation of stability data obtained from a range of sources
- Experience of managing a team of people
Skills & Attributes
Essential
- oGood communication skills including being able to present complex information, share knowledge and influence others
- oProject management and strong organisational skills, including being able to plan and document complex schedules and processes, and prioritise tasks to meet deadlines.
- oCapacity to think strategically, and analyse, evaluate and solve complex problems.
- oConfident user of computer systems, demonstrating attention to detail at all levels, including utilisation and understanding of spreadsheets, in order to identify, record, compare and analyse data from multiple sources
General
Essential
- oApproachable and professional manner, encouraging contribution from others.
- oSelf-aware and acts with integrity.
- oCommitted to continuing professional development for self and others.
- oDeliver excellent customer service to our internal and external customers, helping us to maintain the customer service excellence standard.
Person Specification
Qualifications & Knowledge
Essential
- Master's degree such as Level 7 Pharmaceutical Technology & Quality Assurance (PTQA) (Masters) or Scientist Training Programme (STP) Pharmaceutical Science or relevant pharmaceutical knowledge, and specialist and practical experience of GMP systems management acquired over five years (as defined by MHRA guidance) and equivalent to that required for a post-graduate diploma.
- Management or Leadership qualification or accreditation - or demonstrable equivalent experience.
- Registered with the General Pharmaceutical Council or other relevant professional body.
Desirable
- Accredited Product Approver (S10 Medical Act) and Cleanroom Supervision (CRS) accreditation (or be able to undertake)
- Quality Improvement Accreditation
- Training qualification or accreditation, or equivalent experience
Experience
Essential
- Relevant post-qualification GMP experience providing NHS Aseptic services or within an MHRA licensed unit
- Experience of Quality Risk Management (QRM) or other comprehensive pharmaceutical quality management system
- Experience of undertaking risk assessment, root cause analysis and CAPA, change control
- Experience of stock management of hazardous and time-limited materials, and interpretation of stability data obtained from a range of sources
- Experience of managing a team of people
Skills & Attributes
Essential
- oGood communication skills including being able to present complex information, share knowledge and influence others
- oProject management and strong organisational skills, including being able to plan and document complex schedules and processes, and prioritise tasks to meet deadlines.
- oCapacity to think strategically, and analyse, evaluate and solve complex problems.
- oConfident user of computer systems, demonstrating attention to detail at all levels, including utilisation and understanding of spreadsheets, in order to identify, record, compare and analyse data from multiple sources
General
Essential
- oApproachable and professional manner, encouraging contribution from others.
- oSelf-aware and acts with integrity.
- oCommitted to continuing professional development for self and others.
- oDeliver excellent customer service to our internal and external customers, helping us to maintain the customer service excellence standard.
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).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
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).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
