Head of Production

Main area Pharmacy Grade Band 8c Contract Permanent Hours

• Full time
• Flexible working

37.5 hours per week (Bank and flexible working patterns will be considered)

Job ref 043-PST

Site Imperial Park 5 Town Newport

Salary £75,405 - £86,885 per annum

Salary period Yearly

Closing 13/03/:59

Interview date 17/03/2025

Job overview

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.

Working for our organisation

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.

Detailed job description and main 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.

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.

Person specification Qualifications

• Master's degree such as Level 7 Pharmaceutical Technology & Quality Assurance (PTQA) 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
• Accredited Product Approver (S10 Medical Act) and Cleanroom Supervision (CRS) accreditation
• Quality Improvement Accreditation

Experience

• 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

• Project management and strong organisational skills
• Welsh Language

We are committed to flexible working and equal opportunities.

If you are short listed for interview you will be contacted by email using the email address with which you registered. Please ensure that you check your email account regularly.

Prior consideration for this vacancy will be given to staff awaiting redeployment. We therefore reserve the right to withdraw this advert at any stage.

When applying for this post it is essential that you read the Job Description and Person Specification (where available) and demonstrate how your skills, knowledge and experience meet the requirements of the person specification. Only candidates who clearly demonstrate how they meet the person specification will be shortlisted.

To work in the UK, all candidates who are not UK or Republic of Ireland (RoI) nationals require sponsorship to obtain either a Health and Care visa or Skilled Worker visa, unless you have permission to work via another route. Non UK / RoI candidates wishing to apply should self-assess the likelihood of obtaining a Certificate of Sponsorship by visiting Work in the UK. If you are eligible for the Health and Care visa, application costs are lower and you do not need to pay the annual Immigration Health Surcharge.

Employer certification / accreditation badges

You must have appropriate UK professional registration.

Name Laura-Jayne Keating Job title Deputy Director Pharmacy Services, NWSSP Email address Telephone number