QC Specialist - UK Based

£50.00 - £60 per hour
  1. Permanent
  2. Good Clinical Practice (GCP)
  3. United Kingdom
London
Posting date: 07 Mar 2019
QA.KM.22062_1551974677

ProClinical is advertising a vacancy for a QC Specialist with a prestigious biotechnology company that is developing a new generation of highly selective and potent kinase therapies to dramatically improve the lives of patients with genomically defined diseases. This is an exciting opportunity to join this company's UK based team.

This role will provide onsite quality control support for one of our client partners for drug product manufacturing, release, and stability testing.

Job Responsibilities:

  • Method validation and method transfer activities, including protocol/report review and approval.
  • Supporting forced degradation studies, in-use stability studies, photo stability studies, and other analytical development activities.
  • Supporting analytical investigations.
  • Reviewing in-process, release, and stability data.
  • Supporting additional in-process and analytical testing associated with upcoming validation campaign.
  • Supporting enhancement of QC systems, as needed, to support commercial readiness activities.

Skills and Requirements:

  • A minimum of Bachelor's Degree in Chemistry, Biochemistry or a related discipline.
  • 10 - 15 years in quality control and/or analytical development with extensive experience in method development, validation, and method transfer activities associated with small molecule programs, solid oral dose formulations.
  • Expertise in cGMP and industry expectations for commercial manufacture and testing (lab documentation, OOS/OOT investigations, change control, etc.).
  • Able to integrate and build relationship with CMO to facilitate accelerated problem resolution and adherence to project schedules.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency in MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Keri Marshall at +44 207 440 0679, or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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