Job summary NWSSP Pharmacy Division is recruiting to the position of Head of Production. The successful candidate will demonstrate extensive GMP knowledge and experience gained through production or quality assurance roles. You will be managerially accountable for the staff, service and resources relating to production operational activity for the existing production unit ensuring that it 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), The Human Medicines Regulations and any other relevant statutory requirements, to deliver a timely, high quality and patient-focused service. We are currently in the process of developing a radiopharmacy service with a new build unit based at IP5 adjacent to the current production unit. It is our intention to apply for a variation to our current specials licence to include the operation of this new state of the art facility for which the postholder will be responsible. The postholder will have a key role in developing this service and preparing the unit for MHRA licensing. Main duties of the job The post holder will be responsible at an operational level for holding the licenses for the unit, which may include Manufacturer's License (Specials) (MS), Manufacturer's License (Investigational Medicinal Products) (MIA IMP), Wholesale Dealing Authorisation (WDA), all governed by the Medicines and Healthcare Products Regulatory Authority (MHRA), and the Controlled Drugs License (Misuse of Drugs Act 1971 and Misuse of Drugs regulations (MDR) 2001 governed by the Home Office. In collaboration with the Head of Quality, the post holder will be responsible for maintaining formal contact with the MHRA inspectors and auditors and putting in place effective corrective and preventative actions (CAPA) in response to their inspection process. The ability to speak Welsh is desirable for this post; English and/or Welsh speakers are equally welcome to apply. About us At NHS Wales Shared Services Partnership we have high standards and expect everyone to embrace our values of Listening & Learning, Working Together, Taking Responsibility & Innovating, whilst ensuring trust, honesty and compassion are implicit in everything that we do.We are adaptable, agile and flexible and pride ourselves on being a learning organisation - one where it is safe to make mistakes, where blame is replaced by opportunity, learning and improvement. Innovation is built into everything that we do.We recognise our people regularly and have an Appreciation Station, to encourage staff to applaud exemplary behaviour in one another, alongside an Annual Staff Recognition Award ceremony aligned to our values.We respect and value our people and strive for a culture of compassion and inclusivity. We are a bilingual organisation, and we have a team of Change Champions who advocate 'This is Our NWSSP' our principal change programme. Similarly, PROUD is our new staff network welcoming LGBT colleagues and allies to come together in a safe space for discussions, event planning and the opportunity to build supportive networks.We have a comprehensive benefits package where there is something for everyone, supporting health, engagement and wellbeing and includes an Employee Assistance Programme. We have over 30 Mental Health First Aiders and work in partnership with local and national organisations to ensure the well-being and resilience of our people. Date posted 07 March 2025 Pay scheme Agenda for change Band Band 8c Salary £75,405 to £86,885 a year per annum Contract Permanent Working pattern Full-time, Flexible working Reference number 043-PST005-0325 Job locations Imperial Park 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 Interview date: 17th March 2025 This post may be included in a forthcoming organisational change process, to create the Transforming Access to Medicines (TrAMs) Service. The nature and timescales of the proposed change will be subject to consultation in conjunction with the All-Wales Organisational Change Policy. There is no anticipated risk to employment due to this change. Please contact the recruiting manager if you wish to discuss this further. More information on the TrAMs programme of change can be accessed on the NHS Wales Shared Services (NWSSP) internet : Transforming Access to Medicines - NHS Wales Shared Services Partnership 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 Interview date: 17th March 2025 This post may be included in a forthcoming organisational change process, to create the Transforming Access to Medicines (TrAMs) Service. The nature and timescales of the proposed change will be subject to consultation in conjunction with the All-Wales Organisational Change Policy. There is no anticipated risk to employment due to this change. Please contact the recruiting manager if you wish to discuss this further. More information on the TrAMs programme of change can be accessed on the NHS Wales Shared Services (NWSSP) internet : Transforming Access to Medicines - NHS Wales Shared Services Partnership Person Specification Qualifications 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, Desirable Accredited Product Approver (S10 Medical Act) and Cleanroom Supervision (CRS) accreditation, Quality Improvement Accreditation 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, Skills Essential Project management and strong organisational skills Desirable Welsh Language Person Specification Qualifications 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, Desirable Accredited Product Approver (S10 Medical Act) and Cleanroom Supervision (CRS) accreditation, Quality Improvement Accreditation 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, Skills Essential Project management and strong organisational skills Desirable Welsh Language 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 5 Celtic Way Newport NP10 8BE Employer's website https://nwssp.nhs.wales/ (Opens in a new tab)