Senior QA Specialist - Clinical
SRG
Senior QA Specialist - Clinical
2 days ago by SRG

Title: QA Officer - Clinical
Location: Greater Manchester
Salary: £41,000

About the Role
SRG 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.

Skills
  • Clinical
  • QA
  • Quality Assurance
  • Quality
  • QCP
Reference: 54870216
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