Job summary
Join Our Team: Champion Regulatory Compliance & Drive Continuous Improvement in UHBW Pharmacy Production Department!
We're looking for an enthusiastic and motivated individual to work within our well established department as a Senior Quality Assurance Officer.
If You're Passionate About Making a Difference in Pharmacy Technical Services and Driving Towards Operational Excellence, This Opportunity is for You!
Main duties of the job
- To ensure regulatory compliance, including Good Manufacturing Practice(GMP) of UBHW Pharmacy Production MS Licenced unit
- To communicate effectively with individuals within Pharmacy Production (PPU) , and other technical service departments including Quality Assurance (QA), Parenteral Services Unit (PSU), Radiopharmacy (RP), and Pharmacy Stores and other external suppliers.
- To develop own skills and knowledge and to support in the training and development of other staff.
- Deputising for the Pharmacy Production Quality Assurance lead in their absence.
About us
University Hospitals Bristol and Weston NHS Foundation Trust (UHBW) is one of the largest acute Trusts in the country, bringing together a combined workforce of over 13,000 staff and over 100 different clinical services across 10 different sites, serving a core population of more than 500,000 people across South West England.
UHBW has been rated by the CQC as 'Good' overall and our staff are proud to deliver excellent care to the people of Bristol, Weston and beyond. As a forward-thinking multi-award winning Trust and a digital exemplar committed to improving patient care, our world-leading research and innovations are having a positive local and global impact. Our hospitals are spread across Bristol and Weston, join us and you can enjoy the very best of both worlds; city living within a stone's throw of the countryside or beside the seaside, both with easy access to all that the South West has to offer. UHBW is committed to safeguarding and promoting the welfare of children, young people and vulnerable adults. As an equal opportunities employer actively working towards a diverse workforce we aim to recruit and retain a workforce which represents the rich diversity of the local population at all levels and are committed to designing our services around the needs of individual patients and those around them. Anonymous information will be used from your application in order to ensure we're meeting our pledge.
Job description
Job responsibilities
For a more detailed job description and main responsibilities, please refer to the job description document attached to this vacancy.
Please note this advert might be withdrawn before closing date.
Job description
Job responsibilities
For a more detailed job description and main responsibilities, please refer to the job description document attached to this vacancy.
Please note this advert might be withdrawn before closing date.
Person Specification
Qualifications and Training
Essential
- Relevant science Degree
- Masters or equivalent qualification in Quality Assurance or another aspect of Pharmacy Technical Services
Desirable
- Registration/eligible to be registered with a named relevant professional body
Knowledge and Experience
Essential
- Experience and knowledge of regulatory guidance and standards relating to pharmaceutical quality management (e.g. GMP, GDP and ICH Q10)
- Experience and knowledge of risk management
- Experience in supporting change management
- Experience of deviation management, root cause analyses and CAPA
Desirable
- Lead Auditor experience
- Experience in training and presenting
- Hospital pharmaceutical manufacturing/aseptic preparation service experience and/or QA/QC experience
- Experience of licenced manufacturing activities
Skills and Abilities
Essential
- Exhibit a high level of professionalism
- Ability to communicate clearly and present ideas to large groups of people, small teams and on a one-to-one basis verbally and in a written format
- Ability to liaise with and influence people in a professional manner
- Risk assessment skills
- Methodical approach with a good attention to detail
- Statistical analysis skills
- Organisational skills specifically related to staff, workflow and documentation systems
Person Specification
Qualifications and Training
Essential
- Relevant science Degree
- Masters or equivalent qualification in Quality Assurance or another aspect of Pharmacy Technical Services
Desirable
- Registration/eligible to be registered with a named relevant professional body
Knowledge and Experience
Essential
- Experience and knowledge of regulatory guidance and standards relating to pharmaceutical quality management (e.g. GMP, GDP and ICH Q10)
- Experience and knowledge of risk management
- Experience in supporting change management
- Experience of deviation management, root cause analyses and CAPA
Desirable
- Lead Auditor experience
- Experience in training and presenting
- Hospital pharmaceutical manufacturing/aseptic preparation service experience and/or QA/QC experience
- Experience of licenced manufacturing activities
Skills and Abilities
Essential
- Exhibit a high level of professionalism
- Ability to communicate clearly and present ideas to large groups of people, small teams and on a one-to-one basis verbally and in a written format
- Ability to liaise with and influence people in a professional manner
- Risk assessment skills
- Methodical approach with a good attention to detail
- Statistical analysis skills
- Organisational skills specifically related to staff, workflow and documentation systems
Disclosure and Barring Service Check
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).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
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).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
