Quality Assurance Officer

NHS; Newport (RI); Hybrid; USD 70,000 - 90,000; Full time

Job summary

A leading company in the healthcare sector is seeking a Quality Assurance professional to support the Pharmaceutical Quality Management System. The role involves overseeing environmental testing, managing quality assurance processes, and ensuring compliance with regulatory standards. Ideal candidates will have a strong background in GMP and relevant qualifications, with opportunities for flexible working arrangements.

Benefits

Comprehensive benefits package

Agile working arrangements

Continuous improvement opportunities

Qualifications

• Significant theoretical knowledge of GMP guidance and environmental monitoring principles.
• Experience with UKAS accreditation processes and ISO standards.

Responsibilities

• Assist in maintaining the Pharmaceutical Quality Management System.
• Lead environmental testing activities and manage health and safety guidance.
• Conduct regular QA reviews and oversee product release.

Skills

Microbiology

Aseptic Technique

Education

MSC in Pharmacy

NEBOSH Certificate

Job description

Assist the Head of Quality with the maintenance and development of the Pharmaceutical Quality Management System (PQS) to ensure compliance with licensing, regulations, and legislation.

Lead and support environmental testing activities for NWSSP Pharmacy.

Assist the Head of Quality in the internal audit process of the PQS, including testing projects, validation activities, deviation investigations, and liaising on non-compliances with physical and biological departments.

Provide a GMP-compliant and UKAS-accredited environmental monitoring analytical service, adhering to ISO 17025 and 9001 standards, for NHS and commercial clients, enabling compliance with pharmaceutical, British, European, or international standards. This includes microbiological and air particle monitoring of pharmacy aseptic suites and clean room facilities in Wales and beyond.

Act as the releasing officer for products manufactured under the MS Licence.

Manage health and safety guidance within NWSSP Pharmacy, including COSHH monitoring, and maintain H&S risk assessment files and systems.

Main duties of the job

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

Investigate complex manufacturing and laboratory deviations, ensuring corrective and preventative actions are taken, involving data analysis and change control procedures.

Conduct regular QA reviews of quality exceptions, product issues, and risk assessments, and oversee product release in accordance with regulatory frameworks.

Provide COSHH monitoring services, including gas testing, as needed.

Manage daily temperature monitoring for medicine storage across the Pharmacy.

Lead, supervise, and manage the QA team and related activities, planning workloads and schedules to deliver microbiology services to internal and external clients.

About us

At NHS Wales Shared Services Partnership, we value Listening and Learning, Working Together, Taking Responsibility, and Innovating. We promote agile working, continuous improvement, and an inclusive environment focused on wellbeing and diversity. We strive to provide excellent customer service and offer a comprehensive benefits package. For more information, visit https://nwssp.nhs.wales/working-for-us/

Our agile approach may include remote working and flexible arrangements, fostering learning and community engagement.

Job responsibilities

A full job description and person specification are available within the supporting documents or by clicking 'Apply now' to view in Trac.

Proficiency in Welsh is desirable; applications from English and/or Welsh speakers are welcome.

Person Specification

Experience

• Significant theoretical knowledge of GMP guidance, health and safety advice, and environmental monitoring principles, including clean room testing.
• Experience participating in regulatory audits such as MHRA inspections and DGM (97)52 audits.
• Practical GMP laboratory experience, including health and safety advice.
• Experience with UKAS accreditation processes, ISO 17025 and 9001, and Maldi Tof mass spectrometry.

Qualifications

• MSC in Pharmacy, Pharmaceutical Technology and Quality Assurance, Clinical Pharmaceutical Science, or relevant science field, or equivalent experience.
• Additional relevant qualifications such as NEBOSH Certificate or microbiological qualifications. Knowledge of laboratory quality management systems and NHS procedures.

Skills

• Microbiology and aseptic technique expertise.

Disclosure and Barring Service Check

This post requires a DBS check in accordance with the Rehabilitation of Offenders Act (Exceptions Order) 1975.