NHS Wales Shared Services Partnership

Quality Assurance Officer

The closing date is 13 May 2025

Job summary

Assist the Head of Quality with the maintenance and development of the Pharmaceutical Quality Management System (PQS) system to required licence, regulations and legislation.

Lead on and provide support related to environmental testing for NWSSP Pharmacy

Assist head of quality with internal auditing process of the PQS, including audit of testing projects, validation activities, and deviation investigations and to coordinate and liaise on non-compliances issued to both physical and biological departments.

Provide a GMP compliant and UKAS accredited environmental monitoring analytical service, complying with, ISO 17025 and 9001 to Internal and External NHS and commercial clients, to enable the client to comply with relevant Pharmaceutical, British, European or International standards. This can include the analysis of microbiological and air particle monitoring of Pharmacy aseptic suites, and other clean room facilities in Wales on a regular basis, and further afield when required.

To act as releasing officer for products manufactured under the MS Licence

Responsible for all aspects of Health and Safety (H&S) guidance within NWSSP Pharmacy, providing advice and instruction as necessary including COSHH (Control of Substances Hazardous to Health) monitoring services. Designs, produces and maintains the NWSSP Pharmacy H&S Risk Assessment files and systems.

Main duties of the job

Develop and implement policies, procedures, processes, and systems supporting the manufacture and quality assurance of medicines incorporating quality risk management principles and H&S.

Investigate complex manufacturing and laboratory deviations to ensure corrective and preventative actions are identified and implemented. This will involve collation, comparison, and evaluation of data from a variety of sources and implemented through change control where appropriate.

To undertake a regular QA review of all quality exceptions according to unit procedures in collaboration with the QA team. This involves investigation of product quality issues, defects, clinical and technical risk assessment and management. Product release for sale to external customers in accordance with regulatory frameworks

Provide COSHH (Control of Substances Hazardous to Health) monitoring services (gas testing) when required.

Manage daily the temperature monitoring system for the storage of medicines across the Pharmacy

Responsible for the day-to-day team leadership, supervision and management of own work team and supervision of staff with any QA related activities

To be responsible for planning their own workload, schedules of work and that of others within the team to deliver this complex environmental microbiology service to Pharmacy Technical Services and any external customers.

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

09 May 2025

Pay scheme

Agenda for change

Band

Band 7

Salary

£46,840 to £53,602 a year per annum

Contract

Permanent

Working pattern

Full-time

Reference number

043-HS001-0525

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.

The ability to speak Welsh is desirable for this post; English and/or Welsh speakers are equally welcome to apply.

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.

The ability to speak Welsh is desirable for this post; English and/or Welsh speakers are equally welcome to apply.

Person Specification

Experience

Essential

Have significant theoretical knowledge of GMP guidance, providing health and safety advice, and of the principles and theory underlying environmental monitoring (such as clean room testing).
Experience of participating in regulatory audits such as MHRA inspections as well as DGM (97)52 audits.
Have significant practical experience from working in a GMP testing laboratory, providing health and safety advice.

Desirable

Experience of participation with gaining UKAS accreditation. UKAS ISO 17025 and 9001 Experience of Maldi Tof mass spectrometry

Qualifications

Essential

MSC in Pharmacy, Pharmaceutical Technology and Quality Assurance (PTQA), Clinical Pharmaceutical Science or any other relevant Science or the equivalent relevant experience.

Desirable

Higher education qualification relevant to post. (e.g. NEBOSH Certificate in Health and Safety, Microbiological qualification) Knowledge and experience of other laboratory quality management systems. Knowledge of NHS working procedures.

Skills

Essential

Experience in microbiology and aseptic technique

Person Specification

Experience

Essential

Have significant theoretical knowledge of GMP guidance, providing health and safety advice, and of the principles and theory underlying environmental monitoring (such as clean room testing).
Experience of participating in regulatory audits such as MHRA inspections as well as DGM (97)52 audits.
Have significant practical experience from working in a GMP testing laboratory, providing health and safety advice.

Desirable

Experience of participation with gaining UKAS accreditation. UKAS ISO 17025 and 9001 Experience of Maldi Tof mass spectrometry

Qualifications

Essential

MSC in Pharmacy, Pharmaceutical Technology and Quality Assurance (PTQA), Clinical Pharmaceutical Science or any other relevant Science or the equivalent relevant experience.

Desirable

Higher education qualification relevant to post. (e.g. NEBOSH Certificate in Health and Safety, Microbiological qualification) Knowledge and experience of other laboratory quality management systems. Knowledge of NHS working procedures.

Skills

Essential

Experience in microbiology and aseptic technique

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

Certificate of Sponsorship

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)

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)