Senior QA Specialist - Clinical

Manchester

8 months ago

Applications closed

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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

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