Job summary We are recruiting for a Senior Pharmacist (QA/QC), Deputy Head of Quality Services who shares our vision to be trusted to provide consistently outstanding care and exemplary service to our patients. The Quality Control Department at the Lister Hospital is a specialist unit providing pharmaceutical and scientific services to NHS Trusts, private healthcare providers and commercial organisations. Joining the department, you will be working with staff at levels and become part of a wide range of customer networks and joining our Trust on its existing journey of improvements working closely with the Victoria Mason Institute. We are looking for an enthusiastic, reliable and conscientious individual who has keen eye for detail and a strong work ethic. You will have good knowledge of current regulatory expectations applicable to facilities working under pharmaceutical GMP and significant experience of working in pharmaceutical facilities undertaking sterile or non-sterile manufacture of medicinal products for human use as well as understanding of a wide range of chemical and microbiological analytical techniques. At the heart of everything we do are our core values:Include,Respect, andImprove. We encourage you to embrace these values throughout the recruitment process and in your role with us. Main duties of the job You will support the Head of Quality Services in leadership and development of professional and technical aspects of QA/QC services to both internal and external customers and be responsible for the operational management of the service. You will undertake all duties related to pharmaceutical Quality Assurance and Quality Control including customer and supplier QA visits and audits, management of Quality Exceptions and testing of medical gases. This is a very hands-on position and you will be required to travel to customer sites and undertake work out of hours and at weekends when required. About us At East and North Hertfordshire NHS Trust, we are proud of the range of general & specialist services we provide & our 6,000 or so dedicated staff ensure our patients get the best care. Our ability to be flexible & innovative in the way in which we work and deliver our services to our catchment has never been more important than it is now. We run the following hospitals: The Lister Hospital, Stevenage New Queen Elizabeth II (New QEII), Welwyn Garden City Hertford County, Hertford Mount Vernon Cancer Centre (MVCC), Northwood We have ambitious plans to become an outstanding, patient-led Trust where dedicated staff provide high-quality, compassionate care to our patients. We continue to undergo significant transformation; our staff & patients are at the heart of delivering this ambitious agenda. We understand that finding and starting a new job is an important life decision. If you need reasonable adjustments for a disability, or a life event, such as menopause - so that we can consider your application fairly & to get the best out of you during the selection process, please let us know. We are committed to a positive work life balance for our employees. Employees are entitled to seek to work flexible working patterns & we are committed to listen and consider all requests. Such requests, of course, have to be made & considered formally, & will need to be balanced against service needs, but our starting point will always be to find ways to support making them happen. Date posted 08 November 2024 Pay scheme Agenda for change Band Band 8b Salary £62,215 to £72,293 a year per annum Contract Permanent Working pattern Full-time Reference number 361-PLN-5798250-D Job locations Lister Hospital Stevenage SG1 4AB Job description Job responsibilities Please see the attached Job Description and Person Specification applicant pack for further detailed information regarding this role and a wide range of financial and non-financial benefits offer by the Trust. Job description Job responsibilities Please see the attached Job Description and Person Specification applicant pack for further detailed information regarding this role and a wide range of financial and non-financial benefits offer by the Trust. Person Specification Qualifications/Training Essential Masters degree in Pharmacy (4 year degree) 1 year Pre-Registration training and examination leading to Registration as a pharmacist Current registration with the General Pharmaceutical Council Mandatory CPD to maintain fitness to practice Postgraduate Diploma in Pharmaceutical Technology and Quality Assurance or equivalent postgraduate level of knowledge. Desirable Training as ISO 9001 internal auditor Training as Quality Controller (Piped Medical Gas Systems) as required by HTM 02-01 Previous Experience Essential Significant amount of experience of working in QA/QC role in a facility operating under MHRA manufacturing or WDL licence for medicinal products Demonstrated ability to undertake staff training, day to day management, motivation and appraisals and performance reviews of scientific and technical staff, managing staff sickness and disciplinary issues. Previous experience as a Releasing Officer for medicinal products with final decision making on fitness of the product for patient use. Experience of management and investigations of Quality Exceptions Experience and understanding of analytical techniques and instrumentation including AA, ICP, HPLC, UV, IR, LAL testing Experience in handling hazardous materials and undertaking risk assessments Experience of research projects and investigations. Desirable Registered as Quality Controller for Medical Gas Testing (Pharmaceutical) as per HTM 02-01 and included on the National Register of QC(MGPS) Skills Essential Ability to work with high precision laboratory equipment requiring a high degree of hand-eye co-ordination. Ability to work at speed accurately and concentrate for prolonged periods of time whilst able to deal with interruptions while maintaining accuracy. Auditing skills of facilities and processes. Ability to use the technical knowledge, reasoning and professional judgement to critically review and assess highly complex data and information relating to facilities and products in order to evaluate their suitability for the intended use. Good interpersonal skills and ability to communicate with all levels of staff and customers with confidence, assertiveness and tact. Excellent customer care skills. Desirable Ability to set up and manage databases and use statistics packages. Knowledge Essential Advanced knowledge of both chemical and microbiological analytical techniques Knowledge of current legislation and guidelines relating to pharmaceuticals QA and GMP, GLP, GCP and Quality Systems. Knowledge of Health and Safety at Work act, COSHH legislation and laboratory safety issues. Understanding of waste management regulations. Knowledge of validation requirements for pharmaceutical facilities, equipment and processes. Other requirements Essential Able to travel to customer sites - required and may be necessary out of hours and at short notice Required to be flexible and willing to work out of hours and at weekends to meet customer service demands Required to have the ability to occasionally work at height and also in confined spaces. Required to have the ability to carry and handle moderately heavy equipment. Required to wear personal protective apparel for prolonged periods of time. Knowledge Essential Experience and evidence of engagement around the equality, diversity and inclusion agenda. Role model our Trust values every day Person Specification Qualifications/Training Essential Masters degree in Pharmacy (4 year degree) 1 year Pre-Registration training and examination leading to Registration as a pharmacist Current registration with the General Pharmaceutical Council Mandatory CPD to maintain fitness to practice Postgraduate Diploma in Pharmaceutical Technology and Quality Assurance or equivalent postgraduate level of knowledge. Desirable Training as ISO 9001 internal auditor Training as Quality Controller (Piped Medical Gas Systems) as required by HTM 02-01 Previous Experience Essential Significant amount of experience of working in QA/QC role in a facility operating under MHRA manufacturing or WDL licence for medicinal products Demonstrated ability to undertake staff training, day to day management, motivation and appraisals and performance reviews of scientific and technical staff, managing staff sickness and disciplinary issues. Previous experience as a Releasing Officer for medicinal products with final decision making on fitness of the product for patient use. Experience of management and investigations of Quality Exceptions Experience and understanding of analytical techniques and instrumentation including AA, ICP, HPLC, UV, IR, LAL testing Experience in handling hazardous materials and undertaking risk assessments Experience of research projects and investigations. Desirable Registered as Quality Controller for Medical Gas Testing (Pharmaceutical) as per HTM 02-01 and included on the National Register of QC(MGPS) Skills Essential Ability to work with high precision laboratory equipment requiring a high degree of hand-eye co-ordination. Ability to work at speed accurately and concentrate for prolonged periods of time whilst able to deal with interruptions while maintaining accuracy. Auditing skills of facilities and processes. Ability to use the technical knowledge, reasoning and professional judgement to critically review and assess highly complex data and information relating to facilities and products in order to evaluate their suitability for the intended use. Good interpersonal skills and ability to communicate with all levels of staff and customers with confidence, assertiveness and tact. Excellent customer care skills. Desirable Ability to set up and manage databases and use statistics packages. Knowledge Essential Advanced knowledge of both chemical and microbiological analytical techniques Knowledge of current legislation and guidelines relating to pharmaceuticals QA and GMP, GLP, GCP and Quality Systems. Knowledge of Health and Safety at Work act, COSHH legislation and laboratory safety issues. Understanding of waste management regulations. Knowledge of validation requirements for pharmaceutical facilities, equipment and processes. Other requirements Essential Able to travel to customer sites - required and may be necessary out of hours and at short notice Required to be flexible and willing to work out of hours and at weekends to meet customer service demands Required to have the ability to occasionally work at height and also in confined spaces. Required to have the ability to carry and handle moderately heavy equipment. Required to wear personal protective apparel for prolonged periods of time. Knowledge Essential Experience and evidence of engagement around the equality, diversity and inclusion agenda. Role model our Trust values every day 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. 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. 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 East and North Herts NHS Trust Address Lister Hospital Stevenage SG1 4AB Employer's website https://www.enherts-tr.nhs.uk/ (Opens in a new tab)