Job summary
We are seeking an experienced and motivated Senior Pharmacy Quality Assurance Officer to join our Pharmacy Quality team. This is an exciting opportunity to play a key role in maintaining and developing a robust Quality Management System (QMS) within a pharmacy operation that holds a Wholesale Dealer's Licence (WDA(H)) and is subject to inspection by the Medicines and Healthcare products Regulatory Agency (MHRA). The successful candidate will support the Chief Pharmacist, Responsible Person (RP), and Quality Assurance Manager in ensuring compliance with Good Distribution Practice (GDP), Good Manufacturing Practice (GMP) principles where applicable, Human Medicines Regulations, and all relevant quality and regulatory requirements governing the procurement, storage, distribution, and supply of medicinal products. This role requires a highly organised individual with a strong quality mindset, excellent attention to detail, and the ability to influence quality standards across multidisciplinary teams. If you have a passion to provide an excellent, patient focused pharmacy service within a busy but friendly department, we encourage you to apply.

Main duties of the job

• Support the QA Manager in building, developing and monitoring the quality systems applicable to the pharmacy service with a particular focus on those relating to Manufacturing and Wholesale Dealing.
• To review and approve quality documentation and systems including change management, GMP / GDP deviations, recalls, complaints, product defects.
• As a releasing officer, be responsible for the approval or rejection of raw materials, intermediates, hospital manufactured, commercial products and packaging materials and to keep appropriate records, including maintaining electronic records.
• Ensure adherence to the PQS through appropriate training and motivation of Pharmacy staff.
• Ensure continuing adherence to the requirements of PQS through regular internal inspections and report compliance via the Pharmacy Governance.

About us
The pharmacy department at Chesterfield Royal Hospital is modern, pro-active, forward-thinking and well respected both locally and nationally. We are very committed to the development of pharmacist prescribing and have one of the highest numbers of active pharmacist prescribers in the country. We have won individual and team awards for innovation and clinical excellence in the Trust's staff recognition awards and have won awards at the Pharmacy Congress for our service developments. We have also been shortlisted for Health Service Journal awards. Chesterfield Royal is North Derbyshire's only acute district general hospital, with 24-hour Emergency Department services. We're responsible for providing care and treatment to more than 400,000 people who live in our communities. We are modern, well-resourced and in commuting distance of Sheffield, Derby, Nottingham and close to the Peak District. The Care Quality Commission has rated the Trust as 'Good'. Our vision is to be an outstanding provider of sustainable healthcare services, delivering the best possible care to our patients and being a great place to work for our people.

Job responsibilities

• To support the QA Manager in building, developing and monitoring the quality systems applicable to the pharmacy service with a particular focus on those relating to Manufacturing, Wholesale Dealing and other registerable activity
• To review and approve quality documentation and systems including change management, GMP / GDP deviations, recalls, complaints, product defects etc.
• To undertake and support the preparation of SOPs.
• To ensure satisfactory maintenance and monitoring of the aseptic manufacturing unit and equipment.
• To participate in internal quality audits (Production Unit and Stores and distribution) and external audits as required.
• To approve master worksheets, which relate to or might impinge upon licensable activities.
• As a releasing officer, be responsible for the approval or rejection of raw materials, intermediates, hospital manufactured, commercial products and packaging materials and to keep appropriate records, including maintaining electronic records.
• To evaluate Pharmacy manufacturing batch records, alongside Quality Control reports, prior to release or rejection of a batch
• To be responsible for the review and reporting of all microbiological testing results provided by Quality Control including consultations and discussions of action plans with Production Management if results are outside of recommended guidelines.
• To support and where indicated lead investigations into deviations in quality processes.
• To contribute to external inspection requirements relating to GMP and GDP eg MHRA , CQC , GPhC.
• Ensure appropriate escalation of all risks and outstanding corrective and preventative actions. Maintain relevant records, ensuring accurate data input into all computerised systems.
• To support the operation of the QPulse document management system across the department.
• Collect, interpret and present quality management data and statistics for use in monitoring the quality management system.
• To support the development and application of the QMS to other areas of the pharmacy including the dispensary, and clinical pharmacy services working in association with Senior Pharmacy technicians and pharmacists.

Person Specification
Qualifications
Essential

• A minimum of a bachelor's degree in a Pharmacy, Chemistry or Biology related discipline

Desirable

• Additional Btec/NVQ qualification
• Additional management / supervisory qualification

Experience
Essential

• Experience of managing change
• Experience of audit
• Comprehensive experience of working in a GMP environment

Desirable

• Knowledge / insight into pharmacy Quality systems
• Experience of supervision / mentorship

Skills
Essential

• Able to work within a team
• Confident communicator
• Ability to analyse, interpret and present highly complex information
• Ability to analyse and report on trends, and give specialist advice on findings
• IT literate
• Leadership skills
• Able to manage conflict
• Able to think strategically
• Motivational Skills
• Teaching & presentation skills

Desirable

• Project management skills
• Coaching / mentorship training
• Familiar with pharmacy & medicines related legislation, codes of practice etc
• Knowledge of Pharmaceutical regulatory frameworks

Personal
Essential

• Professional appearance
• Able to work independently
• Able to work under pressure
• Self-motivated
• Ambitious
• Flexible

Values
Essential

• demonstrates proud to CARE values

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.

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).