Job summary Lead on Quality Risk Management (QRM) activity relating to aseptics, radiopharmacy, production and Wholesale Distributor Authorisation (WDA) licence within a single locality, ensuring that the unit meets Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) and Good Distribution Practice (GDP) requirements, Health and Safety at Work, Control of Substances Hazardous to Health (COSHH) and Ionising Radiations (Medical Exposure) Regulations (IR(ME)R), The Human Medicines Regulations and any other relevant statutory requirements, Provide specialised Quality Assurance (QA) expertise and participate in regular audits to drive delivery of a safe, patient-focused, clinical technical service within an effective quality management framework, and ensure maintenance of the manufacturing licenses, approval and relevant accreditations, Undertake investigations in response to Pharmaceutical Quality System (PQS) incidents e.g. errors, near miss and out of specification results, and lead on the documentation and escalation to Quality Assurance Manager, Deliver specialist Quality Assurance (QA) training to staff with Pharmacy Services, NWSSP and external organisations across Wales. Main duties of the job Responsible for use of Quality Risk Management (QRM) principles within the integrated quality system across multi-disciplinary teams, Pharmacy Production, Technical and WDA licence services functions, for a single locality, as required by the MS (Specials) and MIA(IMP) licences, and according to NHS guidance. This involves assessment, control, review and communication of risk related to manufacturing of pharmaceutical products, making a judgement on the probability of harm and severity of harm to patients. The ability to speak Welsh is desirable for this post; Welsh and/or English speakers are equally welcome to apply. About us At NHS Wales Shared Services Partnership we expect everyone to embrace our values of Listening and Learning, Working Together, Taking Responsibility and Innovating. Our organisation encourages an agile working approach and we pride ourselves on being a learning organisation motivated by continuous improvement. We are committed to creating an inclusive workplace that values equality, diversity and inclusion, focussing on the wellbeing and belonging of our people. Excellent customer service is something we strive for, for both our internal and external customers. Offering a comprehensive benefits package, there is something for everyone. To find out more about working for us, the benefits we offer and guidance on the application process please visit https://nwssp.nhs.wales/working-for-us/ NWSSP work in an agile way where possible, all posts will have a contractual base but as part of agile ways of working that may mean working from home and other locations. We also look at how we balance flexibility with community, and how to manage opportunities to learn from each other. Date posted 15 January 2025 Pay scheme Agenda for change Band Band 8a Salary £54,550 to £61,412 a year per annum Contract Permanent Working pattern Full-time Reference number 043-PST002-0125 Job locations Imperial Park Building 5 Celtic Way Newport NP10 8BE 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 Lead on Quality Risk Management (QRM) activity relating to aseptics, radiopharmacy, production and Wholesale Distributor Authorisation (WDA) licence within a single locality, ensuring that the unit meets Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) and Good Distribution Practice (GDP) requirements, Health and Safety at Work, Control of Substances Hazardous to Health (COSHH) and Ionising Radiations (Medical Exposure) Regulations (IR(ME)R), The Human Medicines Regulations and any other relevant statutory requirements, Provide specialised Quality Assurance (QA) expertise and participate in regular audits to drive delivery of a safe, patient-focused, clinical technical service within an effective quality management framework, and ensure maintenance of the manufacturing licenses, approval and relevant accreditations, Undertake investigations in response to Pharmaceutical Quality System (PQS) incidents e.g. errors, near miss and out of specification results, and lead on the documentation and escalation to Quality Assurance Manager, Deliver specialist Quality Assurance (QA) training to staff with Pharmacy Services, NWSSP and external organisations across Wales. 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 Lead on Quality Risk Management (QRM) activity relating to aseptics, radiopharmacy, production and Wholesale Distributor Authorisation (WDA) licence within a single locality, ensuring that the unit meets Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) and Good Distribution Practice (GDP) requirements, Health and Safety at Work, Control of Substances Hazardous to Health (COSHH) and Ionising Radiations (Medical Exposure) Regulations (IR(ME)R), The Human Medicines Regulations and any other relevant statutory requirements, Provide specialised Quality Assurance (QA) expertise and participate in regular audits to drive delivery of a safe, patient-focused, clinical technical service within an effective quality management framework, and ensure maintenance of the manufacturing licenses, approval and relevant accreditations, Undertake investigations in response to Pharmaceutical Quality System (PQS) incidents e.g. errors, near miss and out of specification results, and lead on the documentation and escalation to Quality Assurance Manager, Deliver specialist Quality Assurance (QA) training to staff with Pharmacy Services, NWSSP and external organisations across Wales. Person Specification Qualifications Essential Pharmaceutical Technology and Quality Assurance Experience Essential Experience in MHRA Licenced Facility Desirable Experience Leading in Aseptic Services Person Specification Qualifications Essential Pharmaceutical Technology and Quality Assurance Experience Essential Experience in MHRA Licenced Facility Desirable Experience Leading in Aseptic Services 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). 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. 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). UK Registration Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window). Employer details Employer name NHS Wales Shared Services Partnership Address Imperial Park Building 5 Celtic Way Newport NP10 8BE Employer's website https://nwssp.nhs.wales/ (Opens in a new tab)