Job summary
An exciting opportunity has arisen for a motivated individual to join our friendly and dynamic team, providing high-quality Quality Assurance (QA) services for pharmacy technical services.
We seek a dedicated and experienced leader to enhance our Pharmaceutical Quality Assurance system on-site, ensuring the highest safety and quality standards in patient care.
This role involves managing compliance with MHRA and other regulatory standards, developing quality management systems, and fostering professional relationships with the pharmacy technical services team while leading future planning for batch manufacturing.
The ideal candidate will be a strong leader with excellent decision-making skills, capable of navigating complex situations confidently. A deep understanding of Good Manufacturing Practice (GMP) and a commitment to continuous improvement in QA processes are essential.
By joining our team, you will significantly impact patient safety and product integrity in a collaborative environment. If you are passionate about QA in pharmaceutical healthcare, we invite you to apply.
Main duties of the job
Develop and manage an integrated Pharmaceutical Quality System to ensure high-quality medicines in line with MHRA and other regulatory standards. Provide technical support and advice on QA matters to all areas of pharmacy, the wider Trust and external customers.
Maintain GMP regulatory requirements for both licensed and unlicensed activities. Lead the strategic development of pharmacy QA services to meet local, regional, and national priorities.
In collaboration with the Pharmacy Technical/Cancer Services Manager, respond to GMP audits, develop action plans for deficiencies, and implement timely solutions.
Coordinate self-inspection for the Pharmacy Technical Services Manufacturing Unit and Pharmacy Clinical Trials per GMP and GCP requirements.
Validate pharmacy facilities and computer systems to ensure compliance with regulatory standards, monitor and approve GMP documentation, and coordinate actions for drug recalls and safety notifications. Line management of QA staff.
About us
With a new hospital planned for Watford and work underway to update theatres at St Albans City Hospital, this is an exciting time to join us.
We are building on the success of our award-winning virtual hospital and re-imaging models of care, working ever more closely with partners and making the most of advances in digital healthcare.
Staff wellbeing and development are a priority at our Trust, as is the role of innovation in improving clinical care, outcomes and patient experience.Our vision is Excellent patient care, together and our values are to be empowered, compassionate, professional and inclusive. They capture an important balance across what we must all do as individuals and to support others.At West Herts we offer a variety of flexible working options as we recognise the importance of a good work life balance and the ability to work flexibly.https://www.westhertshospitals.nhs.uk/flexibleworking/We kindly invite you to consider submitting an application.If you have a disability or long-term health condition and should you require support or guidance please contact westherts.recruitment@nhs.netIf you are a Service Leaver, Veteran, Military Reserve, Cadet Force Adult Volunteer, or partner/spouse of those serving please tick "Member of the Armed Forces Community" on the application form.If you do not hear back within 3 weeks of your application, please assume you have been unsuccessful on this occasion.
Job description
Job responsibilities
Please see the job advert for the full job description and person specification attached to the vacancy.
Please complete your application form in full outlining and providing examples of how you meet each of the essential and desirable criteria.
Core hours: Monday to Friday 37.5 hours per week**To participate in Weekend, Bank Holiday, and other departmental rotas, if applicable.
At West Herts we recognise the importance of a good work life balance and the ability to work flexibly. We are delighted to offer a variety of flexible working options for all staff.
Job description
Job responsibilities
Please see the job advert for the full job description and person specification attached to the vacancy.
Please complete your application form in full outlining and providing examples of how you meet each of the essential and desirable criteria.
Core hours: Monday to Friday 37.5 hours per week**To participate in Weekend, Bank Holiday, and other departmental rotas, if applicable.
At West Herts we recognise the importance of a good work life balance and the ability to work flexibly. We are delighted to offer a variety of flexible working options for all staff.
Person Specification
Education
Essential
- Master Degree in Pharmacy (MPharm) or relevant science degree equivalent
- Registered with appropriate regulatory or professional body (E.g. GPhC, RSC or SoB)
Desirable
- Post graduate diploma or MSc in relevant pharmaceutical science discipline (e.g. PTQA) or relevant experience
- Eligible to act as a Qualified Person
Knowledge
Essential
- Suitable knowledge and experience to be named as Quality Controller on MHRA Manufacturing License ('Specials')
- Detailed knowledge of GMP, current legislation and regulations; and ability to apply this knowledge to develop and run Quality Assurance services
- Detailed knowledge of quality aspects of Good Clinical Practice
- Expert knowledge of pharmaceutical aspects of quality assurance with particular reference to aseptic production and practice
- Detailed knowledge and understanding of GMP and pharmacy quality assurance roles within NHS hospitals
Desirable
- Already named on Manufacturing Licence ('Specials') that includes sterile manufacturing
- Knowledge of advanced therapy medicinal products (ATMPs)
- Knowledge of haematological therapies
Experience
Essential
- Substantial full time equivalent post qualification pharmacy practice experience
- Substantial full time equivalent post qualification work in a pharmacy manufacturing/aseptic unit
- Significant NHS knowledge and experience
- Experience of dealing with MHRA and/or other external auditing agencies
- Experience in pharmaceutical manufacturing, including experience of licensed manufacturing unit
- Experience of managing non-compliances and incidents and developing and delivering action plans to address
- Involvement in external and regulatory audits
- Awareness of current national standards, guidelines and service delivery issues relevant to pharmaceutical quality assurance
- Experience of successfully managing human resources issues, e.g. Sickness, disciplinary
- Experience of leading and delivering staff education and development
- Experience of delivering education and training at a postgraduate level
- Experience with qualification requirements for any computerised systems, including computerised validation master plan
Desirable
- Experience of designing, implementing, and managing quality systems
- Experience of formulating and delivering pragmatic action plans to meet regulatory compliance
- Experience of using automation in aseptic services (e.g. BD Cato)
- Experience using electronic QMS systems (e.g. Ideagen Quality Management/Q-Pulse)
Skills
Essential
- Demonstrable leadership skills and ability
- Enthusiastic, hardworking, self-motivated, supportive, flexible and reliable
- Well-developed team working and negotiation skills and ability to put these into practice at all times
- Demonstrated ability to identify problems, analyse root causes and propose solutions for complex problems
- Well-developed and demonstrable project management skills
- High level of attention to detail and quality of work and ability to meet deadlines even in stressful situations
- Able to lead, deliver & prioritise effectively in the face of competing priorities
- Ability to prioritise future QA service developments to meet service needs
- Ability to analyse and critically appraise technical data e.g. stability data
- Ability to develop risk assessments related to pharmaceutical products, data integrity, pharmacy practice and suppliers/manufacturers relevant to hospital pharmacy practice
- Demonstrates ability to achieve desired outcomes and co-ordinate services in the face of diverse unavoidable pressures
- Displays honesty and integrity, is aware of ethical dilemmas relating to practice, and respects confidentiality
- Demonstrable ability to lead and to work effectively as part of a team
- Able to communicate complex, contentious and sensitive information effectively when using clear written and spoken English
- Ability to communicate effectively with colleagues at all levels both within and beyond pharmacy and the Trust
- Leads by example, promoting the highest standards of personal and professional conduct, integrity and probity
- Awareness of the needs of confidentiality
- Awareness of equal opportunities
- Demonstrates ability to manage load handling issues and ensure manual handling risk assessments for all Pharmacy Technical Services activities
Desirable
- Well-developed IT skills and use of IT to manage and monitor quality systems.
- Practical experience of pharmaceutical risk assessment of licensed and unlicensed medicines, pharmacy practice and suppliers/manufacturers
- Demonstrated ability to undertake validated aseptic manipulation requiring fine and accurate motor skills and concentration
- Ability to work at an isolator level for periods of the working time
Person Specification
Education
Essential
- Master Degree in Pharmacy (MPharm) or relevant science degree equivalent
- Registered with appropriate regulatory or professional body (E.g. GPhC, RSC or SoB)
Desirable
- Post graduate diploma or MSc in relevant pharmaceutical science discipline (e.g. PTQA) or relevant experience
- Eligible to act as a Qualified Person
Knowledge
Essential
- Suitable knowledge and experience to be named as Quality Controller on MHRA Manufacturing License ('Specials')
- Detailed knowledge of GMP, current legislation and regulations; and ability to apply this knowledge to develop and run Quality Assurance services
- Detailed knowledge of quality aspects of Good Clinical Practice
- Expert knowledge of pharmaceutical aspects of quality assurance with particular reference to aseptic production and practice
- Detailed knowledge and understanding of GMP and pharmacy quality assurance roles within NHS hospitals
Desirable
- Already named on Manufacturing Licence ('Specials') that includes sterile manufacturing
- Knowledge of advanced therapy medicinal products (ATMPs)
- Knowledge of haematological therapies
Experience
Essential
- Substantial full time equivalent post qualification pharmacy practice experience
- Substantial full time equivalent post qualification work in a pharmacy manufacturing/aseptic unit
- Significant NHS knowledge and experience
- Experience of dealing with MHRA and/or other external auditing agencies
- Experience in pharmaceutical manufacturing, including experience of licensed manufacturing unit
- Experience of managing non-compliances and incidents and developing and delivering action plans to address
- Involvement in external and regulatory audits
- Awareness of current national standards, guidelines and service delivery issues relevant to pharmaceutical quality assurance
- Experience of successfully managing human resources issues, e.g. Sickness, disciplinary
- Experience of leading and delivering staff education and development
- Experience of delivering education and training at a postgraduate level
- Experience with qualification requirements for any computerised systems, including computerised validation master plan
Desirable
- Experience of designing, implementing, and managing quality systems
- Experience of formulating and delivering pragmatic action plans to meet regulatory compliance
- Experience of using automation in aseptic services (e.g. BD Cato)
- Experience using electronic QMS systems (e.g. Ideagen Quality Management/Q-Pulse)
Skills
Essential
- Demonstrable leadership skills and ability
- Enthusiastic, hardworking, self-motivated, supportive, flexible and reliable
- Well-developed team working and negotiation skills and ability to put these into practice at all times
- Demonstrated ability to identify problems, analyse root causes and propose solutions for complex problems
- Well-developed and demonstrable project management skills
- High level of attention to detail and quality of work and ability to meet deadlines even in stressful situations
- Able to lead, deliver & prioritise effectively in the face of competing priorities
- Ability to prioritise future QA service developments to meet service needs
- Ability to analyse and critically appraise technical data e.g. stability data
- Ability to develop risk assessments related to pharmaceutical products, data integrity, pharmacy practice and suppliers/manufacturers relevant to hospital pharmacy practice
- Demonstrates ability to achieve desired outcomes and co-ordinate services in the face of diverse unavoidable pressures
- Displays honesty and integrity, is aware of ethical dilemmas relating to practice, and respects confidentiality
- Demonstrable ability to lead and to work effectively as part of a team
- Able to communicate complex, contentious and sensitive information effectively when using clear written and spoken English
- Ability to communicate effectively with colleagues at all levels both within and beyond pharmacy and the Trust
- Leads by example, promoting the highest standards of personal and professional conduct, integrity and probity
- Awareness of the needs of confidentiality
- Awareness of equal opportunities
- Demonstrates ability to manage load handling issues and ensure manual handling risk assessments for all Pharmacy Technical Services activities
Desirable
- Well-developed IT skills and use of IT to manage and monitor quality systems.
- Practical experience of pharmaceutical risk assessment of licensed and unlicensed medicines, pharmacy practice and suppliers/manufacturers
- Demonstrated ability to undertake validated aseptic manipulation requiring fine and accurate motor skills and concentration
- Ability to work at an isolator level for periods of the working time
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).
