Job summary The Quality Assurance / Quality Control Analyst holds a key operational role ensuring the effective monitoring and testing of environments, product and process in the aseptic manufacturing, microbiological and laboratory services, under a Medicines and Healthcare products Regulatory Agency (MHRA) Manufacturer's "Specials" Licence to ensure delivery of a timely, high quality and patient-focused service across Wales. Main duties of the job To participate in the programme of physical and microbiological monitoring and testing, in accordance with good manufacturing practice (GMP) and good distribution practice (GDP) and good clinical practice (GCP) requirements, Health and Safety at Work, Control of Substances Hazardous to Health (COSHH) and Ionising Radiations regulations (Medical Exposure) Regulations (IR(ME)R), The Human Medicines Regulations, and any other relevant statutory requirements to confirm that control of the environment is maintained within standards. To participate in the Pharmaceutical Quality System (PQS), undertake environmental data recording, including isolators and facilities in which the aseptic products are manufactured, to ensure the medicinal products are safe and effective for patient use, and identify, document and escalate any out of specification and deviations to the QA/QC Laboratory Manager, QA Practitioners and Production Manager. To participate in equipment verification, validation, and calibration, as part of the Validation Master Plan, To record results from QA and QC testing correctly and accurately using pharmacy computer system and other software packages to ensure validity and data integrity 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 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. Offeringa 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 visithttps://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 15 April 2025 Pay scheme Agenda for change Band Band 4 Salary £26,928 to £29,551 a year per annum Contract Permanent Working pattern Full-time Reference number 043-ACS003-0425 Job locations Imperial Parc 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. This role is full time 37.5 hours a week, with a requirement to work a Saturday 1 in every 4 weeks. You will be required to work up to 3 hours on the Saturday. During the week that you work the Saturday, you will work less hours during the week days, to ensure you only work 37.5 hours for that week. 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. This role is full time 37.5 hours a week, with a requirement to work a Saturday 1 in every 4 weeks. You will be required to work up to 3 hours on the Saturday. During the week that you work the Saturday, you will work less hours during the week days, to ensure you only work 37.5 hours for that week. Person Specification Experience Essential Experience working in an MHRA Licenced Manufacturing Unit or comparable production environment. Qualifications Essential BTEC Pharmaceutical Sciences with NVQ Level 3 Pharmacy Services OR The Principles of Aseptic Pharmaceutical Processing (Level 3), OR Equivalent scientific qualification at Level 3 or above, Appropriate Professional Registration Skills Essential Computer skills to include word processing and data entry i.e. spreadsheets and databases. Good numeracy skills including calculations, percentages, decimal, fractions. Manual dexterity to manipulate samples for analysis using highly complex equipment and scientific techniques, and good hand-eye co-ordination. Strong organisational skills Ability to remain calm in a busy environment. Committed to continuing professional development. Person Specification Experience Essential Experience working in an MHRA Licenced Manufacturing Unit or comparable production environment. Qualifications Essential BTEC Pharmaceutical Sciences with NVQ Level 3 Pharmacy Services OR The Principles of Aseptic Pharmaceutical Processing (Level 3), OR Equivalent scientific qualification at Level 3 or above, Appropriate Professional Registration Skills Essential Computer skills to include word processing and data entry i.e. spreadsheets and databases. Good numeracy skills including calculations, percentages, decimal, fractions. Manual dexterity to manipulate samples for analysis using highly complex equipment and scientific techniques, and good hand-eye co-ordination. Strong organisational skills Ability to remain calm in a busy environment. Committed to continuing professional development. 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 Parc 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 Parc Building 5 Celtic Way Newport NP10 8BE Employer's website https://nwssp.nhs.wales/ (Opens in a new tab). Location : Imperial Parc Building 5, Celtic Way, NP10 8BE Newport, United Kingdom