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 various levels and become part of a wide range of customer networks while 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 a 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 an understanding of a wide range of chemical and microbiological analytical techniques.
At the heart of everything we do are our core values: Include, Respect, and Improve. 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, and 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, and 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, and we are committed to listening and considering all requests. Such requests, of course, have to be made & considered formally, and will need to be balanced against service needs, but our starting point will always be to find ways to support making them happen.
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 offered 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 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 in 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 coordination. 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 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.
Employer details
Employer name
East and North Herts NHS Trust
Address
Lister Hospital
Stevenage
SG1 4AB
Any attachments will be accessible after you click to apply.
361-PLN-5798250-E #J-18808-Ljbffr