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Senior QA Specialist - Clinical

SRG
Posted 4 days ago, valid for 5 days
Location

Manchester, Greater Manchester M17 1DJ, England

Contract type

Full Time

In order to submit this application, a Reed account will be created for you. As such, in addition to applying for this job, you will be signed up to all Reed’s services as part of the process. By submitting this application, you agree to Reed’s Terms and Conditions and acknowledge that your personal data will be transferred to Reed and processed by them in accordance with their Privacy Policy.

Sonic Summary

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  • The position of QA Officer - Clinical is available in Greater Manchester with a salary of £41,000.
  • The role requires proven experience in a Good Clinical Practice (GCP) environment and a relevant degree or equivalent experience.
  • Key responsibilities include overseeing quality and compliance for clinical activities, conducting independent QA audits, and participating in the internal audit program.
  • Candidates should have knowledge of regulatory standards and be willing to travel internationally to sites in Europe and the USA.
  • Experience in In-Vitro Diagnostic or Medical Device Regulations and audit experience is desirable for applicants.

Title: QA Officer - Clinical Location: Greater Manchester Salary: £41,000About the RoleSRG are recruiting for a QA Officer with GcP experience to join an innovative company whose technologies form an integral to the advancement of Life science & Healthcare research all over the world. Based at their site in Greater Manchester, you will be responsible for the quality & compliance oversight of Clinical activities, which support the testing & registration of diagnostic tests across global trials. Working on a global basis, you will also have the opportunity to travel to sites across Europe & the USA. Key Responsibilities:

  • Work with the Clinical Affairs team to ensure compliance during trial activities - e.g. closure of deviations, complaints etc.
  • Represent Clinical QA for planned and ongoing clinical trials, including Quality review of clinically relevant documentation
  • Support qualification and perform independent QA audits of clinical study sites
  • Participate in the internal audit program
  • Review Clinical Affairs SOPs

What We're Looking For:

  • A degree or similar qualification in a relevant subject, or equivalent experience.
  • Proven experience in a GCP environment, with knowledge of relevant regulations, standards, guidelines and best practice
  • A working knowledge of In-Vitro Diagnostic or Medical Device Regulations would be advantageous.
  • Audit Experience and knowledge of regulatory inspections would also be desirable.
  • Willingness and availability to travel internationally (Europe + USA).

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.

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In order to submit this application, a Reed account will be created for you. As such, in addition to applying for this job, you will be signed up to all Reed’s services as part of the process. By submitting this application, you agree to Reed’s Terms and Conditions and acknowledge that your personal data will be transferred to Reed and processed by them in accordance with their Privacy Policy.