Senior Pharmacy QA Officer
Job overview
We are pleased to offer an exciting opportunity for the role of a Senior QA Officer for pharmacy at Chesterfield Royal Hospital.
We are looking for a highly motivated candidate with an attention to detail, excellent organisational skills and the ability to work to tight timescales. Also needs to be a great team player and have exceptionally strong interpersonal and communication skills.
The successful candidate will work closely with the QA Manager to develop QA Services, providing and maintaining a safe efficient pharmaceutical service to wards and departments across the Trust.
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 for aseptic services.
Ensure adherence to the PQS through appropriate training and motivation of Pharmacy and QA staff.
Ensure continuing adherence to the requirements of PQS, GMP and GDP through regular internal inspections and report compliance via the Pharmacy Governance.
Working for our organisation
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.
Detailed job description and main 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 liaise with the Quality Manager, Responsible Person and License Holder to ensure that all wholesale dealing activity is compliant with the MHRA Wholesale Dealers License including management and development of the associated Quality System.
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 support the Quality Manager and Principal Pharmacy Technician (Procurement, Distribution & Electronic Stock Management) in training other members of the team and implementing training programmes where required.
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 help develop and support the process for unlicensed medicines.
To support and where indicated lead investigations into deviations in quality processes.
To contribute to external inspection requirements relating to GMP and GDP e.g. 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 an electronic 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 all areas of the pharmacy including the dispensary, and clinical pharmacy services working in association with Senior Pharmacy technicians and pharmacists.
This job description acts as a guide to the responsibilities of the post holder and will be reviewed in consultation with the post holder and amended to meet changing professional and service needs.
Person specification
Qualifications
Essential criteria- A minimum of a bachelor’s degree in a Pharmacy, Chemistry or Biology related discipline
- Additional Btec/NVQ qualification
- Additional management / supervisory qualification
Experience
Essential criteria- Experience of managing change
- Experience of audit
- Comprehensive experience of working in a GMP environment
- Knowledge / insight into pharmacy Quality systems
- Experience of supervision / mentorship
Skills
Essential criteria- 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
- Project management skills
- Coaching / mentorship training
- Familiar with pharmacy & medicines related legislation, codes of practice etc
- Knowledge of Pharmaceutical regulatory frameworks
personal
Essential criteria- Professional appearance
- Able to work independently
- Able to work under pressure
- Self-motivated
- Ambitious
- Flexible
values
Essential criteria- demonstrates proud to CARE values
Flexible Working
If you're looking for flexible or predictable working arrangements, please speak to us about how we might be able to accommodate this. If it works for our service and patients, we will do our best to make it work for you.
COVID19 Vaccination
Chesterfield Royal Hospital NHS Foundation Trust is committed to ensuring the safety of all our staff and patients therefore encourages and supports staff to be vaccinated against COVID19 as this remains the best line of defence against the virus.
UK Points-based immigration system
Applications from job seekers who require sponsorship to work in the United Kingdom (UK) are welcome and will be considered alongside all other applications. Please note that from 1 January 2021, to work in the UK all candidates who are not UK or Republic of Ireland (RoI) nationals require sponsorship unless you have permission to work via another route.Non UK / RoI candidates wishing to apply can self-assess the likelihood of obtaining a Certificate of Sponsorship here Work in the UK - GOV.UK (www.gov.uk).
It is vital that you provide full and accurate details of your current immigration status on the application form. Overseas applicants applying for entry clearance into the UK must present a criminal record certificate from each country they have resided in continuously or cumulatively for 12 months or more in the past 10 years.Guidance can be found here Criminal records checks for overseas applicants - GOV.UK (www.gov.uk)
If you are applying for a vacancy in health or adult social care, you may be eligible to apply for the Health and Care Worker visa instead, which is cheaper to apply for and you do not need to pay the annual immigration health surcharge.
Communications
Communications throughout the application process will be via e-mail therefore please check your e-mail account and Trac account regularly. References are also requested by email (where possible). Therefore to speed up the recruitment process please provide an email address for all referees when completing your application form.
If you require any support in completing the application form, please do not hesitate to contact the HR Support Services team on 01246 513177 and we will be happy to provide assistance.
Please see the attached documents and links in relation to working for Chesterfield Royal Hospital NHS Foundation Trust. In particular, the general conditions of employment and benefits of working for the trust.
This role is part of the integrated health and social care community across Derbyshire, where there are many opportunities to work across different locations and providers developing new and different skills. Whilst this role is initially based in Chesterfield there may be future opportunities to be based at different locations within the health and social care community which we may talk to you about in the future.
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