Job summary
Band 7 post with inner London weighting
Permanent
Location: Based at Royal London Hospital but may be required to travel to all sites within Barts Health NHS Trust
Our group of hospitals provide a huge range of clinical services to people in east London and beyond. We operate from four major hospital sites (The Royal London, St Bartholomew's, Whipps Cross and Newham) and a number of community locations, including Mile End hospital. Around 2.5 million people living in east London look to our services to provide them with the healthcare they need.
We have an exciting opportunity to recruit a QMS Specialist, Band 7 at Pharmacy Technical Services within the Quality team based at Royal London Hospital Pharmacy and Pathology Building (but will be required to travel to all sites within Barts Health NHS Trust).
The aim of this post is to provide support to the Quality managers in maintaining and developing the Pharmaceutical Quality System and QA service provisions. The post holder will be responsible for operationally managing the Pharmaceutical Quality System (PQS), coordinating validation projects, assist in the implementation the risk-based internal inspection program and for tracking and monitoring of Quality metrics. The successful candidate will be expected to complete relevant accreditation and training to familiarise themselves with duties relevant to the post and act as a role model for maintaining high quality standards.
Main duties of the job
The post holder will work within the Quality Assurance team, providing technical leadership-specifically within the Quality Management System and will be responsible for managing and maintaining the document control system and implementation of GxP data integrity principles directly, or through implementing processes and procedures through electronic systems (e.g., Q-Pulse). The post holder will also undertake a range of project activities associated with service development and regulatory compliance.
At Barts Health, we recognise and celebrate the value of our staff. Therefore, dedication to creating and maintaining an outstanding working environment for all staff is essential. In return, you will have access to excellent training and development opportunities.
To discuss this role further, please contact Gift Ikpeama, QMS Manager: gift.ikpeama@nhs.net
About us
Barts Health is one of the largest NHS trusts in the country, and one of Britain's leading healthcare providers.
The Barts Health group of NHS hospitals is entering an exciting new era on our improvement journey to becoming an outstanding organisation with a world-class clinical reputation. Having lifted ourselves out of special measures, we now have the impetus and breathing space to chart a fresh course in which we are continually striving to improve all our services for patients.
Our vision is to be a high-performing group of NHS hospitals, renowned for excellence and innovation, and providing safe and compassionate care to our patients in east London and beyond. That means being a provider of excellent patient safety, known for delivering consistently high standards of harm-free care and always caring for patients in the right place at the right time. It also means being an outstanding place to work, in which our WeCare values and behaviours are visible to all and guide us in how we work together.
We strive to live by our WeCare values and are committed to promoting inclusion, where every staff member has a sense of belonging. We value our differences and fully advocate, cultivate and support an inclusive working environment.
Job description
Job responsibilities
The full job description provides an overview of the key tasks and responsibilities of the role, and the person specification outlines the qualifications, skills, experience, and knowledge required. For both documents, please view the attachment/s below.
Job description
Job responsibilities
The full job description provides an overview of the key tasks and responsibilities of the role, and the person specification outlines the qualifications, skills, experience, and knowledge required. For both documents, please view the attachment/s below.
Person Specification
Qualifications
Essential
- Degree in Pharmaceutical Science, Pharmacy or other relevant scientific subject
Desirable
- Specialist postgraduate certificate/ diploma in Technical Services (e.g., Pharmaceutical Technology and Quality Assurance) or equivalent
- Train the trainer
- Six Sigma certification or equivalent
Experience
Essential
- Proven experience of good performance in previous posts
- Significant work experience in Quality Assurance within a Pharmaceutical or related field
- Experience in project and change management.
- Experience in overall QMS and KPI metrics requirements and presentations
Desirable
- Inspection experience (internal and external)
- Experience of performing validations according to relevant standards
- Experience in chemistry and microbiology techniques
- Experience of radiopharmaceuticals
Knowledge
Essential
- Practical knowledge of GMP (EudraLex Vol.4 and ICH) and QA
- Knowledge of key aspects of GMP, QA and all current legislation and regulations
- Demonstrated knowledge of principles and practices of aseptic/ parenteral e.g., formulation, stability, administration, legal issues
Desirable
- Knowledge of validation principle
- Understanding of GMP requirements and practices of aseptic compounding/ sterile manufacturing
- Knowledge of chemistry and microbiology
- Knowledge of radiopharmaceuticals
Skills
Essential
- Able to communicate complex information effectively using clear written and spoken English.
- Demonstrated ability to influence others.
- Able to complete documentation accurately with attention to detail.
- Able to accurately follow written procedures under pressure.
- Able to work effectively in stressful situations.
- Demonstrates ability to perform accurate complex calculations and numeracy skills
- Ability to plan, prioritise and organise others
- Ability to plan, prioritise and organise self
- Able to meet deadlines.
- Able to work unsupervised and under pressure.
- Intermediate IT skills including email, word processing, spreadsheets, accurate data entry and use of specialist computer programs.
- Good team worker
- Demonstrates ability to deliver lectures, workshops and formal presentations.
- Demonstrates ability to identify, analyse root cause and develop options for complex problems
- Demonstrates ability to manage deviations and develop and review action plans.
- Demonstrates ability to identify QMS problems, prioritise and resolve them.
- Demonstrates ability to assess risk and propose change.
- Demonstrates basic project management skills
Other
Essential
- Demonstrated professional attitude and able to adhere to Trust values.
- Able to meet tight deadlines
- Understand the principles of ALCOA++ plus.
- Enthusiastic, motivated, and hardworking.
- Patient safety focused.
- Good team player.
- Flexible and calm under pressure.
- Good time keeping.
- Interested in expanding knowledge and self-development.
- Awareness of needs of confidentiality.
- Participate in weekend, bank holidays and out of hours work as directed by the line manager
- Basic DBS check as non-patient facing role.
Person Specification
Qualifications
Essential
- Degree in Pharmaceutical Science, Pharmacy or other relevant scientific subject
Desirable
- Specialist postgraduate certificate/ diploma in Technical Services (e.g., Pharmaceutical Technology and Quality Assurance) or equivalent
- Train the trainer
- Six Sigma certification or equivalent
Experience
Essential
- Proven experience of good performance in previous posts
- Significant work experience in Quality Assurance within a Pharmaceutical or related field
- Experience in project and change management.
- Experience in overall QMS and KPI metrics requirements and presentations
Desirable
- Inspection experience (internal and external)
- Experience of performing validations according to relevant standards
- Experience in chemistry and microbiology techniques
- Experience of radiopharmaceuticals
Knowledge
Essential
- Practical knowledge of GMP (EudraLex Vol.4 and ICH) and QA
- Knowledge of key aspects of GMP, QA and all current legislation and regulations
- Demonstrated knowledge of principles and practices of aseptic/ parenteral e.g., formulation, stability, administration, legal issues
Desirable
- Knowledge of validation principle
- Understanding of GMP requirements and practices of aseptic compounding/ sterile manufacturing
- Knowledge of chemistry and microbiology
- Knowledge of radiopharmaceuticals
Skills
Essential
- Able to communicate complex information effectively using clear written and spoken English.
- Demonstrated ability to influence others.
- Able to complete documentation accurately with attention to detail.
- Able to accurately follow written procedures under pressure.
- Able to work effectively in stressful situations.
- Demonstrates ability to perform accurate complex calculations and numeracy skills
- Ability to plan, prioritise and organise others
- Ability to plan, prioritise and organise self
- Able to meet deadlines.
- Able to work unsupervised and under pressure.
- Intermediate IT skills including email, word processing, spreadsheets, accurate data entry and use of specialist computer programs.
- Good team worker
- Demonstrates ability to deliver lectures, workshops and formal presentations.
- Demonstrates ability to identify, analyse root cause and develop options for complex problems
- Demonstrates ability to manage deviations and develop and review action plans.
- Demonstrates ability to identify QMS problems, prioritise and resolve them.
- Demonstrates ability to assess risk and propose change.
- Demonstrates basic project management skills
Other
Essential
- Demonstrated professional attitude and able to adhere to Trust values.
- Able to meet tight deadlines
- Understand the principles of ALCOA++ plus.
- Enthusiastic, motivated, and hardworking.
- Patient safety focused.
- Good team player.
- Flexible and calm under pressure.
- Good time keeping.
- Interested in expanding knowledge and self-development.
- Awareness of needs of confidentiality.
- Participate in weekend, bank holidays and out of hours work as directed by the line manager
- Basic DBS check as non-patient facing role.
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).
