Pharmacy Quality Systems Manager

Oxford University Hospitals NHS Foundation Trust; Oxford; On-site; GBP 45,000 - 60,000; Full time

Job summary

Oxford University Hospitals NHS Foundation Trust is seeking a Pharmaceutical Quality Systems Manager to lead the implementation of the electronic Pharmaceutical Quality System (ePQS) across the Pharmacy directorate. The post holder will ensure ongoing GXP compliance and collaborate with Radiopharmacy and QA/QC teams in GMP-regulated activities.

Key duties include leading ePQS validation, training, and continuous improvement, while supporting regulatory oversight for clinical trials and

Qualifications

• Educated to degree level in relevant subject, e.g. pharmaceutical sciences, microbiology.
• Or Registered Pharmacy Technician with post qualification experience in GMP environment.
• Or Registered Pharmacist.
• Postgraduate certificate or diploma in relevant subject, e.g. QA or Pharmaceutical Technology.

Responsibilities

• Support the HoPQA in implementing the ePQS across user pharmacy teams.
• Act as ePQS lead for system users to ensure adherence and compliance.
• Maintain and develop the ePQS in line with GMP/GXP changes.
• Manage changes to the ePQS, including validation and training.
• Collaborate with senior staff to drive continuous improvement and compliance.
• Involvement in QA systems across Pharmacy, including deviation investigation, CAPA, Change Management.
• Involvement in QC tasks related to environmental monitoring, microbiology, validation, and testing.
• Possible involvement in pharmaceutical release following training.

Skills

Quality Assurance Leadership

CAPA Management

Change Management

Deviation Investigation

Environmental Monitoring

Communication

Team Leadership

Education

Degree in Pharmaceutical Sciences or related

Postgraduate certificate/diploma in Pharmaceutical Technology or QA

Professional registration (IOST/Royal College)

Tools

IT systems knowledge

EU GMP knowledge

Job description

Hello. My name is Mark. I am the Head of Pharmaceutical Quality Assurance. I am seeking a new member of my team to take on the role of Pharmaceutical Quality Systems manager. This will be a diverse role where you will drive the implementation of a new electronic Pharmacetical Quality System, then ensure the system is managed across user departments in the Pharmacy directorate, while ensuring continued regulatory compliance. The role will be key in ensuring regulatory compliance in relation to clinical trials and pharmaceutical production.Main duties of the job The post holder will form part of a small dedicated QA and QC service provided to Radiopharmacy; which holds an Manufacturing Specials (MS) Licence and is regulated by the Medicines and Healthcare Products Regulatory Agency (MHRA), Clinical Trials Aseptic Unit for aseptic dispensing under an exemption of the Human Medicines Regulations 2012, and provides further Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) guidance to other sections within the Pharmacy Department, and other parts of the Pharmacy directorate at the Oxford University Hospitals NHS Foundation Trust. The post holder will be primarily involved in supporting PQS related QA activities and also support the QC services provided to Pharmaceutical Manufacturing and Distribution activities within the Trust. The post holder will utilise their skills, knowledge and expertise related to Pharmaceutical Legislation, the Clinical Trials Directive, Pharmaceutical GMP and Radiation Regulations and Legislation. There is scope for further development of the Quality Systems team to ensure the effective implementation and management of the Pharmacy electronic Pharmaceutical Quality System (ePQS) to aid continued GXP compliance across all user pharmacy teams., 1. Support the HoPQA in the implementation of the ePQS across user pharmacy teams. 2. To act as ePQS lead for system users to ensure continued adherence and compliance. 3. To ensure that the ePQS is maintained and developed in accordance with the user pharmacy teams GXP and in response to changes in regulations and legislation. 4. Ensure any changes to the ePQS are managed appropriately, and ensure any validation or training is identified and implemented as required. 5. Continuously work with Senior staff members in ePQS user departments to drive continuous improvement and compliance. 6. There will be involvement in the Quality Assurance (QA) systems across different areas of Pharmacy. This will include deviaiton investigation, CAPA, Change Management and Management oversight systems. 7. There will be involvement in QC tasks related to environmental monitoring, microbiology, validation and other testing. 8. There is scope to be involved in pharmaceutical release following training., The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.

• Support the HoPQA in the implementation of the ePQS across user pharmacy teams.
• To act as ePQS lead for system users to ensure continued adherence and compliance.
• To ensure that the ePQS is maintained and developed in accordance with the user pharmacy teams GXP and in response to changes in regulations and legislation.
• Ensure any changes to the ePQS are managed appropriately, and ensure any validation or training is identified and implemented as required.
• Continuously work with Senior staff members in ePQS user departments to drive continuous improvement and compliance.
• There will be involvement in the Quality Assurance (QA) systems across different areas of Pharmacy. This will include deviaiton investigation, CAPA, Change Management and Management oversight systems.
• There will be involvement in QC tasks related to environmental monitoring, microbiology, validation and other testing.
• There is scope to be involved in pharmaceutical release following training.

• Educated to degree level in relevant subject, e.g. pharmaceutical sciences, microbiology. Or Registered Pharmacy Technician with post qualification experience in GMP environment. Or Registered Pharmacist., Technical qualification such as postgraduate certificate or diploma in in relevant subject, e.g. Qualification in Pharmaceutical Technology or Quality Assurance, pharmaceutical microbiology, Radiopharmaceuticals or Pharmaceutical Engineering. Professional registration with Institute of Science and Technology or Royal College of Biology/Chemistry, Working knowledge of Pharmaceutical Quality Systems (ICH Q10) Experience of working in a GMP environment. Experience of working in a Pharmaceutical Clean Room. Experience of working in Quality Assurance and a Quality Control laboratory (including experience working with environmental monitoring.) Able to demonstrate evidence of Continuing Professional Development., Prior experience of electronic Pharmaceutical Quality Systems Experience of working in a Licenced Manufacturing Unit. Experience of working in Radiopharmacy and the regulations and restrictions associated with this. Experience of working in relation to Clinical Trials. Experience of undertaking Environmental Monitoring. Experience of interpreting microbiological samples. Experience of releasing Medicines under an MS Licence, or Section 10 unit., Able to communicate effectively with all colleagues. Lead and motivate. Able to promote and evaluate best practice and identify and manage risks Able to manage and support others undertaking research Able to manage non-compliance. Identify problems, analyse root causes and propose solutions to complex problems. Able to develop new systems of work Able to manage the recruitment process and select staff Ability to work in a team as well as autonomously and can delegate authority appropriately Enthusiastic and self-motivated Capable of working under pressure Driving license and ability to drive to different sites for QC or gas testing Able to demonstrate continuing professional development

Desirable criteria

• A thorough understanding of local/regional/national priorities in pharmaceutical quality assurance. Demonstrable awareness of key drivers for the NHS Demonstrable awareness of financial pressures/constraints within the NHS

Technical Skills Essential criteria

• Knowledge of EU Good Manufacturing Practice and the regulations surrounding pharmaceutical manufacture and unlicensed aseptic unit requirements. Knowledge of IT systems and GMP requirements Expert knowledge and the ability to provide specialised information on current legislation and guidelines on all aspects of quality assurance related to the role.

Desirable criteria

• Medical Gas Testing experience and Medical Gas Pipeline working knowledge. Knowledge of IRR2017, IR(ME)R and Environmental Permitting Regulations. Understanding of Class 7 Dangerous Goods transport requirements. Previous involvement in developing a service within pharmacy or QA department. Good Clinical Practice (GCP) knowledge Previous Major Validation Project involvement. Demonstrable knowledge of the validation requirements for pharmaceutical production facilities, equipment, personnel and processes.

Sexual Safety Charter: In 2023 NHS England launched its first sexual safety charter, and our Trust proudly signed it. We pledge zero tolerance for inappropriate sexual behaviour and commit to the ten core principles

Oxford University Hospitals NHS Foundation Trust is one of the largest NHS teaching trusts in the country. It provides a wide range of general and specialist clinical services and is a base for medical education, training and research. The Trust comprises of four hospitals - the John Radcliffe Hospital, Churchill Hospital and Nuffield Orthopaedic Centre in Headington and the Horton General Hospital in Banbury. Our values, standards and behaviours define the quality of clinical care we offer and the professional relationships we make with our patients, colleagues and the wider community. We call this Delivering Compassionate Excellence and its focus is on our values of compassion, respect, learning, delivery, improvement and excellence.

Oxford University Hospitals NHS Foundation Trust is one of the largest NHS teaching trusts in the country. It provides a wide range of general and specialist clinical services and is a base for medical education, training and research. The Trust comprises of four hospitals - the John Radcliffe Hospital, Churchill Hospital and Nuffield Orthopaedic Centre in Headington and the Horton General Hospital in Banbury. Our values, standards and behaviours define the quality of clinical care we offer and the professional relationships we make with our patients, colleagues and the wider community. We call this Delivering Compassionate Excellence and its focus is on our values of compassion, respect, learning, delivery, improvement and excellence.

Oxford University Hospitals promotes a safe, respectful hiring environment. If you want to make a difference with us, come and join our team. Together, we will uphold the highest standards of care and professionalism.