Job summary
We have the unique opportunity to offer a QA QMS Specialist post to an enthusiastic and motivated individual who wishes to develop their technical knowledge through working in busy units.
This post will work across three sites including St Bartholomew's Hospital, The Royal London Hospital and Whipps Cross University Hospital. The three sites combined provide cytotoxic, parenteral nutrition, sterile manufactured products, CIVAS, Specials and Over-labelling and re-packaging to a variety of wards and clinics within the hospitals and to over 200 customers throughout the UK and Ireland.
This post aims to oversee the management and continuous improvement of the QA Pharmaceutical Quality System, this role will require to liaising with third parties regularly and discussing areas of improvement.
Main duties of the job
The QA QMS Specialist is accountable for driving results in a fast paced environment, continuously challenging performance in regards to quality standards, systems and operating procedures. Responsibilities include providing support towards quality reviews and approval of documents, data, protocols, qualifications, change controls, deviations, and investigations, complaints, and CAPA activities.
This post will ensure that Pharmacy Technical Services teams are up to date with QMS training and ensure QA staff receives continues training, preparing training modules and conducting training sessions.
So if you are a highly skilled, motivated and QA & regulatory focus, already experienced in a manufacturing role within hospital or industry and looking for the next career step then you should consider applying for this role.
Delivery of an excellent, responsive, safe and timely service is critical. On-going personal development opportunities are provided to facilitate this. We are therefore looking for people willing to show their commitment to delivering excellence and working with us to make pharmacy a great place to be, for all staff in our wider team.
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
We are dedicated to being an outstanding place to work and will work with you to get the best experience. We know flexible working is not a one size fits all and will mean something different to everyone. We are inclusive, so if you are interested in flexible working, please speak to the recruiting manager.
**We reserve the right to close this vacancy prior to the advertised closing date, once a sufficient number of applications has been received and we regret that we are unable to provide notification if your application is unsuccessful**
Please note: When calculating the basic salary for sponsorship, HCAS (High-Cost Area Supplement) is not included for non-medical roles. This ensures fairness and consistency within our organisation, as some of our sites fall under inner HCAS, while others are classified as outer HCAS.
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.
For more information on this post please contact:
Gift Ikpeama (QMS Manager) , e-mail: Gift.Ikpeama@nhs.net and Clarissa Coker , e-mail Clarissa.coker@nhs.net (Head of Pharmacy Quality)
Job description
Job responsibilities
We are dedicated to being an outstanding place to work and will work with you to get the best experience. We know flexible working is not a one size fits all and will mean something different to everyone. We are inclusive, so if you are interested in flexible working, please speak to the recruiting manager.
**We reserve the right to close this vacancy prior to the advertised closing date, once a sufficient number of applications has been received and we regret that we are unable to provide notification if your application is unsuccessful**
Please note: When calculating the basic salary for sponsorship, HCAS (High-Cost Area Supplement) is not included for non-medical roles. This ensures fairness and consistency within our organisation, as some of our sites fall under inner HCAS, while others are classified as outer HCAS.
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.
For more information on this post please contact:
Gift Ikpeama (QMS Manager) , e-mail: Gift.Ikpeama@nhs.net and Clarissa Coker , e-mail Clarissa.coker@nhs.net (Head of Pharmacy Quality)
Person Specification
Qualifications
Essential
- NVQ BTEC Level 3 in pharmaceutical Science Or Biomedical Science or equivalent or a relevant Science degree
- Registered with Pharmaceutical Council (GPhC) or relevant Regulatory body
- NVQ Level 3 Science Manufacturing Technician (SMT
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
- MSc Pharmaceutical Technology Quality Assurance
- Radio Pharmacy Life Science & medicine - kings college course
- ILM L4 - leadership and management
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
- Demonstrate ability to problem solve and use initiative
Desirable
- Knowledge of validation principles
- Understanding of GMP requirements and practices of aseptic compounding/ sterile manufacturing
- Knowledge of Chemistry and microbiology
- Knowledge of radiopharmaceuticals
- Knowledge of all aspects of GMP, QA and all current Legislations
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
Desirable
- Demonstrates effective customer services skills
- Demonstrates ability to deliver staff training
- Critical Appraisal Skills
- Line Management Experience
Other
Essential
- Understand the principles of ALCOA++ plus
- Basic DBS check as non-patient facing role.
Other
Essential
- Demonstrated professional attitude and able to adhere to Trust values
- Able to meet tight deadlines
- 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
Person Specification
Qualifications
Essential
- NVQ BTEC Level 3 in pharmaceutical Science Or Biomedical Science or equivalent or a relevant Science degree
- Registered with Pharmaceutical Council (GPhC) or relevant Regulatory body
- NVQ Level 3 Science Manufacturing Technician (SMT
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
- MSc Pharmaceutical Technology Quality Assurance
- Radio Pharmacy Life Science & medicine - kings college course
- ILM L4 - leadership and management
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
- Demonstrate ability to problem solve and use initiative
Desirable
- Knowledge of validation principles
- Understanding of GMP requirements and practices of aseptic compounding/ sterile manufacturing
- Knowledge of Chemistry and microbiology
- Knowledge of radiopharmaceuticals
- Knowledge of all aspects of GMP, QA and all current Legislations
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
Desirable
- Demonstrates effective customer services skills
- Demonstrates ability to deliver staff training
- Critical Appraisal Skills
- Line Management Experience
Other
Essential
- Understand the principles of ALCOA++ plus
- Basic DBS check as non-patient facing role.
Other
Essential
- Demonstrated professional attitude and able to adhere to Trust values
- Able to meet tight deadlines
- 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
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).
