Parexel

Qualified Person

Company
Parexel
Location
Harrow, United Kingdom
Salary
Competitive
Posted
07 Jan 2021
Closes
06 Feb 2021
Ref
64162BR
Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Job Description

We are currently recruiting a QP to work in our Early Phase Unit in London to assist in the conduct of studies and releaseInvestigational Medicinal Products (IMP) as per Clinical Trial Regulations 2004, in accordance with agreed protocols, the principles of International Conference on Harmonization, Good Clinical Practice and Good Manufacturing Practice.
This is a part time, permanent position.

EssentialFunction
  • To assist in the conduct of Phase 1 studies across all therapeutic areas in accordance with ICH Good Clinical Practice (GCP) and following local regulatory requirements and relevant Standard Operating Procedures (SOP's).
  • QP release of Investigational Medicinal Products (IMP) as per Clinical Trial Regulations 2004, in accordance with agreed protocols, the principles of International Conference on Harmonization, Good Clinical Practice and Good Manufacturing Practice.
  • Provide guidance on technical and regulatory requirements for the conduct of clinical trial and advice on cGMP and cGCP issues
  • Ensuring correct procedures are followed and the process for assembly and supply of study medication (investigational medicinal products) for dosing of subjects in clinical trial studies is controlled.
  • Ensuring Quality Control procedures are followed
  • Assist with audits (internal/ external).

  • KeyAccountabilities
  • Responsible for QP certification and release of batches of subject doses assembled, in compliance with GMP and regulatory requirement
  • Responsible for Quality Control ensuring that viable and non-viable environmental monitoring results comply with design specifications and primarily packaging materials are approved /released before use.
  • Responsible for setting up IMP Terms of Supply as required
  • Ensuring documentation of the receipt, storage, preparation, drug accountability of investigational medicinal product (IMP) are in accordance with to cGCP and EU GMP guidelines
  • Provision of guidance/ input into set up of assembly activities and design of worksheets/ documentation and procedures for assembly of IMPs as required.
  • Participation in investigation of quality issues/ deviations arising from assembly activities or facility (IMP assembly/ and storage areas)
  • Other duties as required.
  • Qualifications

    Education
  • Pharmacy, Biological or Chemical Science degree
  • Eligible to act as an MIA (IMP) QP and be named on MIA (IMP) Licence
  • Member of a recognised regulatory body (such as The Royal Pharmaceutical Society of Great Britain, The Institute of Biology or The Royal Society of Chemistry)




  • Minimum Work Experience
  • Experience within the Pharmaceutical Industry, CRO or Hospital Pharmacy.
  • Experience with Clinical Trial Supplies (Manufacture and Packaging)
  • Experience with EU QP certification and release of IMP.
  • Experience with certification and release of IMP assembled/ manufactured within a Phase I Unit.
  • GMP and/ GCP auditing experience.
  • Why Work at Parexel

    There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

    That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

    How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

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