Aseptic, QA and Clinical Trial Pharmacist

2 weeks ago


Manhattan, United States The Royal Marsden Full time

Job overview Aseptic, QA and Trials Pharmacist Band 7 or (Band 6 to 7 Progression) - Chelsea Based (Expected to cover cross site if needed) A unique opportunity has arisen for an enthusiastic, highly motivated, dynamic pharmacist to join the pharmacy aseptic team at the Royal Marsden NHS Foundation Trust. This is an incredible opportunity to be joining the team due to various exciting upcoming projects. The trust has implemented EPIC systems which can go paperless in terms of production. i.e. no paper worksheets, using validated computer/portable screen devices in the clean rooms and isolators.  Implementation of a new mini microbiology lab/ team to carry out in house QC testing. We will be interested in your ability to show drive, ambition, willingness to learn, manage busy workloads, organisational and team working skills. Main duties of the job To join the Aseptic/QA services and Clinical Trials Pharmacy team at the Royal Marsden NHS Foundation Trust liaising closely with other pharmacy team members and Hospital staff. The post holder will assist and work closely with the objectives of the senior managers across clinical trials and aseptic services. To work with the clinical trials team and contribute to the set-up, delivery, and ongoing management for IMP studies. To support the safe delivery to meet the demands of an unlicensed section 10 aseptic service for RMH. Detailed job description and main responsibilities Aseptic Services To assist the Aseptic Services Management team in the day-to-day management and provision of the cytotoxic reconstitution and aseptic services (including gene therapy) across sites. Ensure appropriate working conditions are adhered too and that the relevant principles of Good Manufacturing and Dispensing Practice, and those of the Health and Safety at Work Act are applied at all times. Ensure all professional aspects of technical services are incorporated into the chemotherapy and aseptic services procedure manuals and other aseptic services documentation. Ensure that aseptic services policies and procedures are adhered to, and production records and training documents are completed appropriately. Pharmacy Quality Assurance To assist the aseptic department to ensure the service is fully compliant with the relevant regulatory guidelines. Assist in maintaining the Quality Management System (QMS) in accordance with the unlicensed NHS facility requirements as documented in procedures and policies, aid in development in response to changes to regulations and legislation and help improve production processes. Assist in reviewing and approving data generated from Micro testing (including verification, calibration and validation for methods and equipment/accreditation results) Supporting the Aseptic Services Management team with CAPAs and Change Controls as per Quality Assurance of Aseptic Preparation Services (QAAPS) and MHRA guidelines. Assist in completion of patient impact assessments and product quality risk assessments via deviation system Raise deviations in the QMS, assist in minor & major investigations and ensuring effective implementation of identified CAPAs. Support critical deviations General Duties and Responsibilities To gain working knowledge of the aseptic/QA and clinical trial sections of the pharmacy and therefore be able to work competently and with minimum supervision in any section as and when required to do so. To assist in the training and accreditation of trainee pharmacists, pharmacists, technicians and other health care professionals, and in the induction of all new staff. To act as a mentor and provide advice to junior members of the team and assist in their professional and personal development To undertakes any other duties consistent with the nature of the post, which may vary from time to time, as requested by the pharmacy manager. Person specification Education/Qualifications Essential criteria GPhC registered Pharmacist Desirable criteria Working towards Diploma in Pharmacy, Pharmaceutical Quality Assurance diploma/post graduate certificate or equivalent Experience Essential criteria For Band 6 Level applications will be considered for those without any experience related to aseptic/clinical trials/QA Desirable criteria For Band 7 Level - Candidates are expected to have significant NHS Pharmacy Aseptic/QA/Clinical Trials experience Skills/Abilities/Knowledge Essential criteria Good organisational/time management Good interpersonal skills Contribute to the team Good communication skills Good presentation and problem solving skills Awareness of current developments in pharmacy as well as technical pharmacy services Ability to use Microsoft Office applications eg. Word and Excel Desirable criteria Be able to interpret and work with complex clinical trial and aseptic documents/guidelines Good leadership skills The Royal Marsden values diversity and is committed to the recruitment and retention of underrepresented minority groups. We particularly welcome applications from Black, Asian and minority ethnic candidates, LGBTQ+ candidates and candidates with disabilities.  As a Disability Confident Employer, we are working to create a workplace that enables all staff to reach their full potential. We are committed to this because we know that greater diversity and inclusion will lead to an even greater positive impact for the people we serve. Due to the high volumes of applications we receive, we reserve the right to close any adverts before the published closing date once we have received a sufficient number of applications. We advise you to submit your application as early as possible to prevent disappointment. Please ensure your information is accurate to avoid errors with processing your application Flu Vaccination – What We Expect of our Staff At The Royal Marsden we have an immune compromised patient population who we must protect as much as we can against the flu virus. Each year, seasonal flu affects thousands of people in the UK. Occurring mainly in winter, it is an infectious respiratory disease capable of producing symptoms ranging from those similar to a common cold, through to very severe or even fatal disease. The wellbeing of our staff and patients is of the upmost importance to us, and it is the expectation of The Royal Marsden that all patient-facing staff have an annual flu vaccination, provided free of charge by the Trust. Employer certification / accreditation badgesThis link is external and opens in a new tabThis link is external and opens in a new tabThis link is external and opens in a new tabThis link is external and opens in a new tabThis link is external and opens in a new tabThis link is external and opens in a new tabThis link is external and opens in a new tab Applicant requirements You must have appropriate UK professional registration. The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.



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