Senior QA Specialist - Clinical

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.