Job summary
An exciting opportunity has arisen for an enthusiastic Quality Assurance Specialist to join the Pharmacy Production team at University Hospitals Bristol and Weston NHS Trust. You will be joining a friendly and progressive department and we are seeking an enthusiastic and motivated individual to join our team.This is a fantastic opportunity for the right individual to take the next step and develop their career in technical services and management.
You will join a team of Pharmacists and Technicians supervising and overseeing the department, implementing new developments and ideas and ensuring that current and future Good Manufacturing Practice and professional standards are achieved.The unit holds 'Specials' and Investigational Medicinal Product (IMP) licences as well as aseptic dispensing of products under Section 10 exemption and Pharmacist supervision.The Pharmacy Production department provides a wide range of aseptic and non-sterile products including monoclonal antibodies, gene therapy, CIVAS, and the manufacture and dispensing of IMPs.
There are a number of exciting developments in the pipeline, providing opportunities to further develop and broaden your skills.
Main duties of the job
The Pharmacy Production Quality Assurance Lead is responsible for the oversight of the quality assurance activity in Pharmacy Production to ensure that all regulatory standards are adhered to and best practice implemented at all times. The post holder will work closely with the Production pharmacist team and the Production technical team to ensure the highest quality and safety standards of the products manufactured in Pharmacy Production.
The Pharmacy Production Quality Assurance Lead will:
- Be responsible for the efficient running of the Pharmacy Quality System (PQS) for Pharmacy Production.- Ensure that all validation activities are completed in a timely manner in line with GMP.- Ensure departmental SOPs are current and compliant with GMP.- Be responsible for product development and ongoing review of current products.- Ensure MHRA and AAPS audit compliance is maintained.
About us
University Hospitals Bristol & Weston NHS Foundation Trust (UHBW) is one of the largest acute Trusts in the country, with a workforce of over 13,000 staff and 100+ different clinical services across 10 sites, serving a population of over 500,000 people across Bristol and Weston. UHBW has been rated by the CQC as 'Good' overall and our staff are proud to deliver excellent care to patients. As a forward-thinking multi-award winning Trust, committed to improving patient care, our world-leading research and innovations are having a positive local and global impact.
Join us and you can enjoy city living, be in the countryside or by the seaside, with easy access to all the South West offers. 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 create a workforce that represents the diversity of our community and are committed to designing our services around the needs of patients and their loved ones. 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.
Job description
Job responsibilities
For a more detailed job description and main responsibilities, please refer to the job description document attached to this vacancy.
Person Specification
Skills and Abilities
Essential
- Excellent written / oral communication skills and able to communicate with staff at all levels from a wide range of disciplines.
- Excellent prioritisation, organisation and time management skills.
- Confident at making informed decisions and managing risk.
- Able to accurately perform complex calculation and interpret complex data.
- Able to produce complex reports / business plans / policies and procedures / research documents.
- Able to demonstrate good staff management and project management skills.
Desirable
- Clear understanding of national standards and transformation plans.
Knowledge and Experience
Essential
- Demonstrable experience working within in a section 10 aseptic preparation unit and/or an MHRA licensed unit.
- Experience of quality assurance activities involving aseptic preparation.
- Demonstrable track record of achieving objectives.
- Significant, relevant GMP experience in a senior role.
- Experience of line managing staff
Desirable
- Experience of participation in MHRA and/or EL(97)52 audits.
Qualifications and Training
Essential
- Pharmacist, Pharmacy Technician or Clinical Scientist (pharmaceutical science).
- Statutory professional registration or eligible to register with GPhC as a Pharmacist, Pharmacy Technician or HCPC as a Clinical Scientist.
- MSc/Postgraduate Diploma in Pharmaceutical Technology & Quality Assurance or STP training.
- Recent evidence of technical service update training
Desirable
- Participation in regional and or national working groups (NHS futures, PASG)
Person Specification
Skills and Abilities
Essential
- Excellent written / oral communication skills and able to communicate with staff at all levels from a wide range of disciplines.
- Excellent prioritisation, organisation and time management skills.
- Confident at making informed decisions and managing risk.
- Able to accurately perform complex calculation and interpret complex data.
- Able to produce complex reports / business plans / policies and procedures / research documents.
- Able to demonstrate good staff management and project management skills.
Desirable
- Clear understanding of national standards and transformation plans.
Knowledge and Experience
Essential
- Demonstrable experience working within in a section 10 aseptic preparation unit and/or an MHRA licensed unit.
- Experience of quality assurance activities involving aseptic preparation.
- Demonstrable track record of achieving objectives.
- Significant, relevant GMP experience in a senior role.
- Experience of line managing staff
Desirable
- Experience of participation in MHRA and/or EL(97)52 audits.
Qualifications and Training
Essential
- Pharmacist, Pharmacy Technician or Clinical Scientist (pharmaceutical science).
- Statutory professional registration or eligible to register with GPhC as a Pharmacist, Pharmacy Technician or HCPC as a Clinical Scientist.
- MSc/Postgraduate Diploma in Pharmaceutical Technology & Quality Assurance or STP training.
- Recent evidence of technical service update training
Desirable
- Participation in regional and or national working groups (NHS futures, PASG)
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).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
Additional information
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).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
Employer details
Employer name
University Hospitals Bristol and Weston NHS Foundation Trust (UHBW)
Address
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
Employer's website
https://www.uhbw.nhs.uk/ (Opens in a new tab)
