Job summary Barts Health Pharmacy Technical Services (PTS) is part of Barts Health NHS Trust and has seen significant changes over the last few years, and the evolving team of pharmacists, technicians, scientists and assistants in the Pharmacy Quality Department continue to ensure and maintain high standards of Good Manufacturing Practices (GMP) across the four licensed 'Specials' units that are managed over three hospital sites. An exciting opportunity has arisen to recruit a Deputy Head of Quality to support the Head of Quality in developing, delivering and maintaining the high standards required to ensure patient medication is produced to the highest quality. Provisional interview date:11th December 2024 Main duties of the job The post holder is required to assist in maintaining the integrated quality systems across the licensed units. They will gain in-depth knowledge and understanding of the management, regulatory and control of the four sites. They will be involved in continuous improvement project work associated with service development to maintain the reliability and capabilities of the quality unit. Candidates should have a qualification in Pharmacy or a relevant science degree with membership of the relevant professional body. They will have experience of working within a GMP facility, with thorough understanding of current Good Manufacturing Practices and Good controlled Laboratory Practices (GcLP). Working in a hospital setting, linked to an MHRA Licensed Pharmacy Manufacturing unit as well as managerial experience is also desirable. The applicant must be efficient, organised, proactive and able to forge relationships with a wide range of staff within and beyond pharmacy quality. Working within the team and autonomously across multiple sites, will be able to deal with queries and make risk-based decisions to maintain compliance with the licence requirements as well as safe supply of medicines to the patients. The post holder will also be required to travel between multiple sites. 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. We particularly welcome applications from Black, Asian and minority ethnic candidates as they are underrepresented within Barts Health at this band. Date posted 07 November 2024 Pay scheme Agenda for change Band Band 8b Salary £70,387 to £80,465 a year Per annum inc Contract Permanent Working pattern Full-time, Flexible working Reference number 259-6771405GCS Job locations Royal London Hospital London E1 2ES 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. 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 further information or to arrange an informal visit, please contact: Clarissa Coker (Head of Quality) on 0203 246 0267 or e-mailclarissa.cokernhs.net. 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. 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 further information or to arrange an informal visit, please contact: Clarissa Coker (Head of Quality) on 0203 246 0267 or e-mailclarissa.cokernhs.net. Person Specification Experience Essential Demonstrate knowledge of cGMP/GLP/Quality systems Demonstrates experience in the application of Human Resource Policies and Procedures Proven experience of good performance in previous posts and managing teams in GMP environments Demonstrates ability to identify facility and equipment problems, troubleshoot, prioritise, and resolve them. Advise on quality issues with manufacturing teams to maintain GMP and patient safety Demonstrates ability to manage QMS including deviations, CAPAs Change Controls and develop and review action plans Demonstrates expert experience & ability to produce production & quality related documentation Demonstrates expert experience in performing and receiving audits from external agencies Demonstrates competent experience and ability to successfully undertake a range of technical projects Desirable Experience of working in a QA/QC laboratory Experience of medical piped gases Experience of working with radiopharmaceuticals Demonstrated knowledge of pharmaceutical microbiology. Skills Essential Demonstrated ability to identify problems, analyse root cause and propose solutions for complex problems Able to manage deviations and incidents and develop and review action plans to resolve them Able to develop and review options appraisal's and identify the most appropriate option Effective leadership skills Advanced IT skills including email, word processing, spreadsheets, databases, accurate data entry and use of specialist computer programmes Methodical with good attention to detail Desirable Able to write business cases Knowledge Essential Demonstrated expert technical knowledge of GcLP and cGMP, and a proven ability to apply this knowledge to maintain, develop and validate quality systems Knowledge of the eight core principles of ISO9001 Quality Management Knowledge of Aseptic Practices Working knowledge of gap analysis and action plans Knowledge of all regulatory Standards: UK and EU legislation regarding cGMP, GcLP, cGCP Knowledge of COSHH and health and safety at work Knowledge of conducting Internal and external self-inspection and Audits Expert knowledge of validation Expert knowledge of project management Desirable Knowledge of development and validation of various analytical techniques and radiopharmacy Knowledge of development and validation of various analytical techniques and radiopharmacy Experience in design, development and undertaking stability studies. Qualifications Essential Master's degree in pharmacy or relevant Science Degree Full membership of a relevant professional body e.g. General Pharmaceutical Council (GPhC), or Royal Society of Chemistry (RSC) or Biology (RBS) Desirable Specialist postgraduate Diploma/MSc in technical Services (e.g. National Course in Pharmaceutical Technology and Quality Assurance) or equivalent work based technical experience and underpinning knowledge Experience of Hospital environments Other Essential Excellent verbal and written communication and presentation skills suitable for a range of audiences, including chairing meetings Experience in giving presentations to diverse audiences. Awareness of the need of confidentiality Skills Essential Good team working skills Organisation and prioritisation of workload to meet deadlines Desirable Able to communicate effectively with all health care professionals, colleagues, contractors, service providers Excellent verbal and written communication skills Other Essential Required to wear specialised clean room clothing and appropriate Personal Protective Equipment (PPE) Person Specification Experience Essential Demonstrate knowledge of cGMP/GLP/Quality systems Demonstrates experience in the application of Human Resource Policies and Procedures Proven experience of good performance in previous posts and managing teams in GMP environments Demonstrates ability to identify facility and equipment problems, troubleshoot, prioritise, and resolve them. Advise on quality issues with manufacturing teams to maintain GMP and patient safety Demonstrates ability to manage QMS including deviations, CAPAs Change Controls and develop and review action plans Demonstrates expert experience & ability to produce production & quality related documentation Demonstrates expert experience in performing and receiving audits from external agencies Demonstrates competent experience and ability to successfully undertake a range of technical projects Desirable Experience of working in a QA/QC laboratory Experience of medical piped gases Experience of working with radiopharmaceuticals Demonstrated knowledge of pharmaceutical microbiology. Skills Essential Demonstrated ability to identify problems, analyse root cause and propose solutions for complex problems Able to manage deviations and incidents and develop and review action plans to resolve them Able to develop and review options appraisal's and identify the most appropriate option Effective leadership skills Advanced IT skills including email, word processing, spreadsheets, databases, accurate data entry and use of specialist computer programmes Methodical with good attention to detail Desirable Able to write business cases Knowledge Essential Demonstrated expert technical knowledge of GcLP and cGMP, and a proven ability to apply this knowledge to maintain, develop and validate quality systems Knowledge of the eight core principles of ISO9001 Quality Management Knowledge of Aseptic Practices Working knowledge of gap analysis and action plans Knowledge of all regulatory Standards: UK and EU legislation regarding cGMP, GcLP, cGCP Knowledge of COSHH and health and safety at work Knowledge of conducting Internal and external self-inspection and Audits Expert knowledge of validation Expert knowledge of project management Desirable Knowledge of development and validation of various analytical techniques and radiopharmacy Knowledge of development and validation of various analytical techniques and radiopharmacy Experience in design, development and undertaking stability studies. Qualifications Essential Master's degree in pharmacy or relevant Science Degree Full membership of a relevant professional body e.g. General Pharmaceutical Council (GPhC), or Royal Society of Chemistry (RSC) or Biology (RBS) Desirable Specialist postgraduate Diploma/MSc in technical Services (e.g. National Course in Pharmaceutical Technology and Quality Assurance) or equivalent work based technical experience and underpinning knowledge Experience of Hospital environments Other Essential Excellent verbal and written communication and presentation skills suitable for a range of audiences, including chairing meetings Experience in giving presentations to diverse audiences. Awareness of the need of confidentiality Skills Essential Good team working skills Organisation and prioritisation of workload to meet deadlines Desirable Able to communicate effectively with all health care professionals, colleagues, contractors, service providers Excellent verbal and written communication skills Other Essential Required to wear specialised clean room clothing and appropriate Personal Protective Equipment (PPE) 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. Certificate of Sponsorship 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. Certificate of Sponsorship 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 Barts Health NHS Trust Address Royal London Hospital London E1 2ES Employer's website https://www.bartshealth.nhs.uk (Opens in a new tab)