Lead Quality Assurance

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Applicants are invited to apply in Welsh. Any application submitted in Welsh will not be treated less favourably than an application made in English
Job Overview
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.

Working for our organisation

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

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.

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

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.

Person specification

Experience
Essential criteria

• Experience in MHRA Licenced Facility

Desirable criteria

• Experience Leading in Aseptic Services

Qualifications
Essential criteria

• Pharmaceutical Technology and Quality Assurance or equivalent level and subject qualification

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.

Applicant requirements

You must have appropriate UK professional registration.

The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.

Welsh language skills are desirable

Documents to download

• Job Description and Person Specification (PDF, 456.4KB)
• Swydd ddisgrifiad & Manyleb y person - Cymraeg (PDF, 696.3KB)
• Functional requirements form (PDF, 1.2MB)
• NWSSP Recruitment Services Privacy Notice (PDF, 696.3KB)
• NWSSP - About Us (PDF, 6.6MB)
• NWSSP - Our Benefits 2023 (PDF, 487.5KB)
• NWSSP - Buddion (PDF, 491.0KB)
• PCGC -Amdanom (PDF, 6.7MB)
• Guidance Notes for Applicants April 2024 (PDF, 278.7KB)
• IMTP Summary PDF, 13.7MB)
• IMTP Summary Cymraeg (PDF, 13.7MB)

Further details / informal visits contact

Name Sarah Crawford Job title Head of Quality - Pharmacy Email address