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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.
