Quality Assurance / Quality Control Analyst
If you are looking to join NWSSP, please see the additional information below that may be of interest to you: -
Our “Benefits” video has been created to highlight and showcase some of the benefits of working for the NHS and NWSSP:- https://youtu.be/zX3x046SDhg
The “Tops Tips – Be Yourself” video has been designed to support candidates applying for roles with NWSSP. We have outlined 8 key steps to help candidates articulate their capabilities and experience when completing applications with NWSSP. https://youtu.be/qe3ibY8b6m4
Applicants are invited to apply in Welsh. Any application submitted in Welsh will not be treated less favourably than an application made in English
Please be advised that there is a temporary top up for Bands 2 and 3 to reflect the incorporation of the top up to the living wage of £12.60 per hour - £24,638 per annum.
This temporary top up will be in place until the annual pay uplift for 2025/26 is confirmed
Job overview
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.
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 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.
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 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 criteria- Experience working in an MHRA Licenced Manufacturing Unit or comparable production environment.
Qualifications
Essential criteria- 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 criteria- 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.
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.