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.