Category: Job Adverts

Churchill Hospital

Qualified Person

Churchill Hospital, Oxford

Band 8C – £63,751 – £73,664

37.5 hours per week, part-time working considered

Fixed Term – 1 year (with strong possibility of extension)

Oxford is the principal site in Europe recruiting to clinical studies involving hyperpolarised Xenon imaging, notably using this method to investigate ongoing breathlessness in long-COVID. Oxford is also the first site in the world to investigate the application of hyperpolarised carbon-13 in studying cardiovascular disease.

Are you ready to bring your QP expertise to this research team to support NHS patients with access to new and novel therapies? Do you have excellent professional, organisational and delivery skills, which you can contribute to the manufacturing of medicines under MS and MIA(IMP) licenses and management of the associated quality systems? The range of medicines is currently small but specialised, and you will work closely with the Principal Investigator, Production Manager and Clinical Research Operations Manager to set-up and deliver an exciting range of trials. You will gain invaluable experience from working across sites within the organisation in delivering research excellence.

QP requirements:

  • BSc in Pharmacy, Chemistry, Biology, or related subject
  • Eligible to act as a Qualified Person under the requirements of 2001/83/EC
  • QP Certification of investigational medicinal products
  • Experience in managing a pharmaceutical quality system.
  • Experience of MHRA MIA(IMP) variations and MHRA inspections
  • Review and release of starting materials, intermediates and finished products
  • Release of unlicensed medicinal products (‘Specials’)

Oxford Radiology Research Unit

The Oxford Radiology Research Unit (ORRU) is based at the Oxford University Hospitals NHS Trust and runs in partnership with the Oxford Biomedical Research Centre (BRC) and the University of Oxford.

ORRU leads and facilitates research and development activity with specific focus on imaging within protocols. ORRU contributes to clinical research studies to ensure the quality and provision of clinical trial services is in accordance with all relevant legislation, regulations and guidelines including Good Manufacturing Practice (GMP), International Conference on Harmonisation – Good Clinical Practice (ICH-GCP) and Clinical Trials Directives

Closing date: Not confirmed

Click here to apply

 

Nuffield Department of Medicine, Jenner Institute

Senior Quality Assurance Manager

Nuffield Department of Medicine, Jenner Institute

Clinical BioManufacturing Facility, Old Road, Headington, Oxford, OX3 7JT

Grade 8: Grade 8: £41,526 – £49,553 with a discretionary range to £54,131 per annum

We are seeking a highly motivated Senior Quality Assurance Manager for the Jenner Institute, Clinical BioManufacturing Facility (CBF) ensuring compliance with Good Manufacturing Practice (GMP) and other regulatory requirements. This is an excellent opportunity to work in an academic GMP facility delivering innovative biological products to early phase clinical trials.

You will manage the Quality Assurance Team, reporting to the Head of Quality, and will take the lead in performing delegated duties of the Qualified Person (QP) are performed ensuring prompt batch release of Investigational Medicinal Products, as defined in Annex 16 of the GMP Guide.

In addition, you will be the QA Technical Expert for; Sterile Medicinal Products (GMP Guide Annex 1);   Biological Medicinal Products (GMP Guide Annex 2) and/or Advanced Therapy Medicinal Products (GMP Guide Part IV); Investigational Medicinal Products (GMP Guide Annex 13).

You will also manage all day to day operations of the QA team, which currently consists of five members of staff. This will require oversight of the QA review of GMP documentation as well as input into risk assessments, investigations and other Quality Management System (QMS) Documentation. This role will also include undertaking self-inspections and external audits as well as the provision of advice and support for all CBF staff.

You will be educated to degree level in life sciences or engineering. You will be competent and experienced in managing all aspects of Quality Assurance and compliance management procedures within a GMP regulated environment. You will have sound knowledge of GMP guidelines (EudraLex Volume 4), the Medicines for Human Use (Clinical Trials) Regulations 2004 and its amendments, ICH Q9 and Q10 and the ability to interpret these in a non-commercial environment.

Applications for this vacancy are to be made online and you will be required to upload a supporting statement and CV as part of your online application. Your supporting statement must explain how you meet each of the selection criteria for the post using examples of your skills and experience.

Click here to apply

This post is offered full-time on a fixed term contract for 3 years in the first instance and is funded by the Department.

Please quote 151769 on all correspondence. Only applications received before 12.00 noon on Wednesday 21 July 2021 will be considered.

NSF 18/03/2021

NSF International

Executive Director, Pharma Biotech Consulting

Internal title: Senior Pharma Biotech Consultant

Competitive Salary + Benefits

Permanent, Full Time

UK or Ireland

The expert team at NSF Health Sciences is on a mission to protect and improve human health around the world. We work with leading manufacturers of pharmaceuticals, medical devices, dietary supplements, cosmetics and clinical research throughout the product lifecycle. Our services include training and education, consulting, regulatory guidance, corporate compliance as well as auditing, testing, certification and R&D services. NSF Health Sciences is part of NSF International, a global public health and safety organization focused on the food we eat, the water we drink and the health care products we use. Headquartered in Michigan, USA, with +3000 employees worldwide, NSF offers an exciting opportunity to play a pivotal role in public health at an exception time. Learn more at www.nsf.org

To support, establish, develop, and manage the business interests of NSF Health Sciences we are currently looking for an Executive Director, Pharma Biotech Consulting, who will have a particular focus on operations emanating from the UK office.

In this role you will design, deliver, and maintain a range of bespoke training courses together with the provision of auditing and consultancy services to new and existing NSF Health Sciences Pharma Biotech clients. Whilst managing a team of associates engaged by NSF Health Sciences Pharma Biotech in the delivery of services.

YOUR PROFILE:

  • Bachelor’s degree with QP experience within the Pharma industry
  • Expertise including Biotechnology, sterile products and IMP would be an advantage
  • Ability to interpret and present highly complex and strategically significant information
  • Mastery knowledge of regulations and guidance related to the products within the portfolio of services
  • Documented successful experience within industry or regulators
  • Willingness and ability to travel up to 50% of the time

WHAT NSF OFFERS YOU 

 

If working in an environment that promotes creativity, thought leadership, close collaboration and importantly mitigates risk to human health, then NSF can offer you the chance to make a difference. With its commitment to diversity and gender equality, let NSF help you to build your career aspirations in a multi-cultural setting where everyone’s voice is heard.  

 

Through working alongside highly experienced colleagues you will learn and develop to become an expert in the provision of state of the art solutions to client needs, by developing and protecting the supply of medicines to patients and end users. 

 Click here to apply