Lead Quality Assurance (QA) Practitioner

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.

Employer details

Employer name

NHS Wales Shared Services Partnership

Address

Imperial Park Building 5

Celtic Way

Newport

NP10 8BE

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Employer details

Employer name

NHS Wales Shared Services Partnership

Address

Imperial Park Building 5

Celtic Way

Newport

NP10 8BE

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