Category: Job Adverts

Custom Pharma

Quality Manager – QP

Permanent, full-time

Brighton & Hove, East Sussex

Competitive salary and benefits package

This is an exciting time to join us.   Following significant investment and continued growth we are building a new, bespoke manufacturing and pilot plant facility which is currently under construction.

Working within a dynamic SME environment with an established and customer focussed quality culture this is an excellent opportunity to develop your wider business and leadership skills.  We are looking for a permanent, full-time Quality Manager who will be responsible for day-to-day management of the QA Systems team and play a key role within cross functional quality improvement projects.  This is a significant part of the role.

You will also act as a Qualified Person for our 2 current Brighton & Hove sites in conjunction with other named QPs and must be eligible to act as a QP in the UK (Commercial and IMP) and have demonstrated experience as a releasing QP (ideally oral solid dosage).

Company Description

About Custom

Custom Pharma Services is an established contract development and manufacturing organisation with a broad portfolio of commercial and development products and has a proven track record of designing and developing new oral solid dose formulations to support clinical studies, followed by process development and scale up to successfully launch these new products.  Our ‘Clinical to Commercial’ offering is achieved through an integrated new product development and introduction system that ensures we have a Flexible, Agile and Streamlined approach to deliver on Time and meet our customers’ expectations.

Custom is a great place to work where teamwork and support is encouraged, where every individual is valued and supported to achieve their full potential because if you can, then Custom Can! 

About the role

In summary the role comprises:

  • Eligible to act as a QP in the UK (Commercial and IMP)
  • Demonstrated experience as a releasing QP (ideally oral solid dosage)
  • Clinical and product development experience, ideally as a QP on an MIA(IMP) licence.
  • Working knowledge of compendial requirements, analytical techniques and laboratory instrumentation.
  • Robust technical knowledge of EU GMP and GDP regulations and guidelines
  • Experience of QMS operation and optimisation
  • Previous experience as a Quality Manager
  • Familiarity and experience of deploying continuous improvement tools and techniques (e.g., Lean Six Sigma)
  • Displays energy and drive for GMP compliance in a collaborative and practical manner.
  • Ability to enhance the Quality Culture at Custom
  • Excellent communication and interpersonal skills with the strength of character to keep a team focussed on objectives and success criteria
  • Demonstrates a passion for quality excellence
  • Ability to identify opportunities for process & operational improvements and implement appropriate changes to deliver these benefits
  • Passion for “right-first-time” processes
  • Ability to perform investigations with business SMEs to determine true root cause and implement effective CAPA

Benefits package includes: Individual bonus payment based on successful performance.

Pension; Life Assurance; Holiday; Health Plan and Subsidised Gym

Free parking onsite with easy access to the A27, 5 minutes’ walk from Hove Station.

How to apply

Please submit your application asap including a covering letter explaining how your skills and experience meet requirements of the role.

Click here to apply

If you have any questions or would like an initial conversation with our Recruitment Manager, Jane Austen, please contact her via email: Jane.Austen@custompharma.co.uk

Applicants must have the right to work in the UK.

Successful candidates will be required to complete a basic disclosure check

www.custompharma.co.uk

 

 

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BAP Pharma

Senior Quality Manager (RPi) – BAP Pharma UK

Location: Marlow, Buckinghamshire, UK
Salary: Competitive base salary + performance based bonus
Ref: BAPQPUK
Hours: Full Time
Contract Type: Permanent
Experience Level: Experienced

Come and join us!!

BAP Pharma is a global leader and still the fastest growing company involved in the supply, packaging and labelling of medicines used in ground-breaking clinical trials. Now in our 10th year of trading, we’re set to beat our targeted turnover of €250M in 2021, with more growth to come. We have grown on average at 45% per year in each of the last 2 years. And to maintain our growth, we have invested significantly in new sites globally. Currently moving to state-of-the-art new facilities in both UK and USA and a recently establish EU facility in Germany. Come and join the team, develop your skills, and grow as our exciting, development and expansion continues. We are now looking for people with a passion for great customer service and doing the right thing, to help us take the business forward. Our people are our greatest asset, our future is exciting, come join us!

Job Description

BAP have an amazing opportunity for a Senior Quality Manager who can act as our RPi. The Senior Quality Manager’s role is to ensure that BAP Pharma is compliant with MHRA guidelines concerning medicines & Home Office guidelines for Controlled Drugs.

The Senior Quality Manager is responsible for safeguarding product users against potential hazards arising from poor distribution practices and to be knowledgeable of UK and EU legislation.

Job Requirements

Essential

  • Eligible Responsible Person in accordance with EU Directive 2001/83/EC
  • Knowledge of Eudralex, The Rules Governing Medicinal Products in the European Union, Volume 4 Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use.
  • Good Understanding of the Wholesale Dealer’s Licence.
  • Knowledge of The Human Medicines Regulations (UK SI 2012 1916).
  • Understanding of Directive 2001/83/EC as amended, of the Community Code relating to medicinal products for human use.
  • Understanding of, The New Guidelines for Good Distribution Practice of medicinal products for human use.
  • Knowledge of Commission guidelines for GDP of medicinal products for human use (2013/C 68/01).
  • BSc in Pharmacy, Chemistry, Biology, or related subject

Preferable

  • Experience with either Comparator Sourcing, Clinical Packaging & labelling or Unlicensed Medicines
  • Familiarity with I.T programmes such as; eQMS, ERP, WMS and FMD systems
  • Supported QP release of IMP and/or unlicensed medicinal products
  • Lead Quality Teams
  • Experience in hosting supplier/ client audits and regulatory audits such as MHRA
  • MSc in Pharmacy, Chemistry, Biology, or related subject

Competencies

  • Attention to Detail and Thoroughness.
  • Concern for Standards.
  • Excellent communication skills.
  • Diplomacy with MHRA, Home Office and Clients.
  • Interpersonal awareness and sensitivity.
  • Flexibility and Adaptability.
  • Tenacity

Work Conditions

  • Reports directly to the Managing Director.
  • From time-to-time overtime may be required to meet project deadlines.
  • Sitting for extended periods of time.
  • Ability to work under own initiative and as part of a team.

 Click here to apply 

 

 

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: 26th November 2021

Click here to apply