Band 8c – Qualified Person Investigational Medicinal Products (IMP)

Job title:

Band 8c – Qualified Person Investigational Medicinal Products (IMP)

Company

NHS

Job description

The postholder will undertake Qualified Person (QP) responsibilities as defined in the QP Code of Practice. They will be a named QP on MHRA license MIA(IMP) 11149 held by the Royal Free London NHS Foundation Trust in accordance with the requirements of European Community Statutory Directive 2001/83/EEC / UK SI 2012/1916 (as amended). The role includes the responsibility for certifying Investigative Medicinal Products (IMP), ensuring compliance of operations with regulatory requirements, QP declaration for imported products and will manage the portfolio of QP activities.The postholder will need to meet the requirements of the QP as detailed in articles 49 and 50 of Directive 2001/83/EU / UK SI 2012/1916 (as amended), and SI 2004/1031, and be an eligible QP that can be named on a MIA(IMP).The postholder must be able to extend their authority and ensure that all regulatory requirements are met and is able to influence the development of policy decisions and strategic plans. To meet these requirements, the postholder must have a strong track record in quality assurance gained in the pharmaceutical industry manufacturing sterile products. Extensive knowledge, interpretation, and application of quality management within a GxP environment is essential. In addition, the postholder must be able to work independently and be an effective communicator with good presentational skills and experience of training.Main duties of the jobPRIMARY RESPONSIBILITIESThe postholder will be responsible for carrying out legal duties as a QP in accordance with Directive 2001/83/EC / UK SI 2012/1916, ensuring compliance with the requirements of Annex 13 of the EU Guidance on GMP for clinical trial IMPs and where relevant Annex 16 Certification by a QP and batch release.The postholder will be certifying all manufacturing steps up to the finished product and is responsible for ensuring that each finished medicinal product batch has been manufactured and certified in accordance with GMP, the terms of the MIA(IMP), the Product Specification File and the IMPD as per Directive 2001/83/EC / UK SI 2012/1916 and EU Clinical Trial Regulation (CTR, 536/2014) / as SI 2004/1031.Detailed information is in the attached job description.About usOur trust has around 10,000 staff serving 1.6 million patients. This large scale organisation provides an unprecedented opportunity for us to continue our pioneering work, particularly in finding ways to deliver even better care to our patients. With many specialities which are underpinned by a strong research agenda, the Royal Free is renowned for providing excellent patient care.Everyone is welcome at Royal Free London NHS Foundation Trust. We’re proud of our diversity and continue to undertake new initiatives to advance equality for all.The Pharmacy department of the Royal Free London NHS Trust is a friendly, progressive, and expanding unit dedicated to providing the highest standards of pharmaceutical care and service in this large, internationally renowned teaching hospital. Quality improvement and cost-effective, safe use of medicines is at the forefront of everything we do. We have over 300 staff working across each site in all areas of pharmacy.We are an integral part of London Cancer and UCL Partners, the largest Academic Health Science System in the UK. We host one of the most extensive licensed manufacturing suites in the UK and provide cytotoxic, CIVAs and specials services to the Trust and home care patients. We additionally have an MIA (IMP) License and manufacture investigational products (IMPs) across the full range of products.Date posted26 March 2025Pay schemeAgenda for changeBandBand 8cSalary£82,462 to £93,773 a year per annum inclusive of HCASContractPermanentWorking patternFull-timeReference number391-RFL-7058850Job locationsRoyal Free HospitalPond StreetLondonNW3 2QGJob descriptionJob responsibilitiesIn addition to the Primary Responsibilities summarised above, the post holder will also have responsibilities under the following headings:REGULATORY COMMUNICATIONEDUCATION AND TRAININGPOLICY AND SERVICE DEVELOPMENTFINANCIAL AND PHYSICAL RESOURCESLEADING AND MANAGINGINFORMATION RESOURCESRESEARCH AND DEVELOPMENTDetailed information is in the attached job description Job descriptionJob responsibilitiesIn addition to the Primary Responsibilities summarised above, the post holder will also have responsibilities under the following headings:REGULATORY COMMUNICATIONEDUCATION AND TRAININGPOLICY AND SERVICE DEVELOPMENTFINANCIAL AND PHYSICAL RESOURCESLEADING AND MANAGINGINFORMATION RESOURCESRESEARCH AND DEVELOPMENTDetailed information is in the attached job descriptionPerson SpecificationRoyal Free World Class ValuesEssential

• oDemonstrable ability to meet the Trust Values

Education & professional QualificationsEssential

• oEligible Qualified Person (QP) that can be named on MIA (IMP)
• oRegistered with the relevant professional body as a pharmacist or scientist recognised by Regulatory Authority to permit QP status as per article 49 of Directive 2001/83/EC / UK SI 2012/1916 (as amended), Schedule 7.
• oScience degree or PhD (or equivalent)
• oCurrent Good Clinical Practice Certification

Desirable

• oIf a pharmacist, also registered with the General Pharmaceutical Council (GPhC)

ExperienceEssential

• oExperience in the healthcare/pharmaceutical industry gained in an MHRA approved pharmaceutical production environment.
• oSolid foundation in clinical trials, QA and understanding of quality requirements through the clinical supply chain.
• oExperience hosting regulatory inspections.
• oAbility to learn new techniques and how they may be used to develop novel IMP release tests.
• oExperienced Pharmaceutical Auditor.
• oPrevious managerial or supervisory experience with proven leadership skills.
• oGood understanding of pharmaceutical document systems.
• oDemonstrable experience of working in technical services
• oExperience of multidisciplinary working
• oExperience in delivering education and training
• oExperience of writing and implementing standard operating procedures
• oKnowledge of GCP, GMP, GDP, IMP and clinical trials medicines legislation
• oExperience in IT
• oExperience of supervising staff and workload on a day-to-day basis

Desirable

• oExperience importing clinical trial material manufactured outside the UK/EU.

Skills and aptitudesEssential

• oGood written and verbal communication
• oGood interpersonal skills when dealing with patients and staff
• oGood negotiation skills and the ability to influence medical, pharmacy and management staff
• oGood management skills with respect to time, staff and available resources
• oGood presentation skills
• oGood teaching and training skills
• oAbility to manage risk
• oAbility to implement best practice
• oAbility to work both alone and as part of a team
• oAbility to work accurately under pressure
• oAbility to evaluate service quality
• oAbility to identify own training needs
• oAbility to critically evaluate available literature
• oGood understanding of current national standards and guidelines
• oGood understanding of clinical risk and governance
• oComputer literate with knowledge of Microsoft Office applications including Word and Excel

Personal Qualities and AttributesEssential

• oProfessional appearance and demeanour
• oEnthusiastic, well motivated and hard working
• oDemonstrates initiative
• oAdaptable
• oApproachable
• oAssertive
• oResilient
• oSelf-aware & reflective
• oReliable with an excellent attendance record

OthersEssential

• oOccasionally be required to work outside normal working hours to meet deadlines.

Person SpecificationRoyal Free World Class ValuesEssential

• oDemonstrable ability to meet the Trust Values

Education & professional QualificationsEssential

• oEligible Qualified Person (QP) that can be named on MIA (IMP)
• oRegistered with the relevant professional body as a pharmacist or scientist recognised by Regulatory Authority to permit QP status as per article 49 of Directive 2001/83/EC / UK SI 2012/1916 (as amended), Schedule 7.
• oScience degree or PhD (or equivalent)
• oCurrent Good Clinical Practice Certification

Desirable

• oIf a pharmacist, also registered with the General Pharmaceutical Council (GPhC)

ExperienceEssential

• oExperience in the healthcare/pharmaceutical industry gained in an MHRA approved pharmaceutical production environment.
• oSolid foundation in clinical trials, QA and understanding of quality requirements through the clinical supply chain.
• oExperience hosting regulatory inspections.
• oAbility to learn new techniques and how they may be used to develop novel IMP release tests.
• oExperienced Pharmaceutical Auditor.
• oPrevious managerial or supervisory experience with proven leadership skills.
• oGood understanding of pharmaceutical document systems.
• oDemonstrable experience of working in technical services
• oExperience of multidisciplinary working
• oExperience in delivering education and training
• oExperience of writing and implementing standard operating procedures
• oKnowledge of GCP, GMP, GDP, IMP and clinical trials medicines legislation
• oExperience in IT
• oExperience of supervising staff and workload on a day-to-day basis

Desirable

• oExperience importing clinical trial material manufactured outside the UK/EU.

Skills and aptitudesEssential

• oGood written and verbal communication
• oGood interpersonal skills when dealing with patients and staff
• oGood negotiation skills and the ability to influence medical, pharmacy and management staff
• oGood management skills with respect to time, staff and available resources
• oGood presentation skills
• oGood teaching and training skills
• oAbility to manage risk
• oAbility to implement best practice
• oAbility to work both alone and as part of a team
• oAbility to work accurately under pressure
• oAbility to evaluate service quality
• oAbility to identify own training needs
• oAbility to critically evaluate available literature
• oGood understanding of current national standards and guidelines
• oGood understanding of clinical risk and governance
• oComputer literate with knowledge of Microsoft Office applications including Word and Excel

Personal Qualities and AttributesEssential

• oProfessional appearance and demeanour
• oEnthusiastic, well motivated and hard working
• oDemonstrates initiative
• oAdaptable
• oApproachable
• oAssertive
• oResilient
• oSelf-aware & reflective
• oReliable with an excellent attendance record

OthersEssential

• oOccasionally be required to work outside normal working hours to meet deadlines.

Expected salary

£82462 – 93773 per year

Location

North West London

Job date

Fri, 28 Mar 2025 08:45:37 GMT

To help us track our recruitment effort, please indicate in your email/cover letter where (globalvacancies.org) you saw this job posting.