Senior QA Specialist - Clinical

SRG; Manchester; On-site; GBP 41,000; Full time

Job summary

A leading company in Life Sciences is looking for a QA Officer - Clinical in Greater Manchester. This role involves overseeing compliance of clinical activities for global trials, requiring proven GCP experience and the ability to conduct audits. Candidates must be ready to travel internationally to sites across Europe and the USA.

Qualifications

• Degree or equivalent experience required.
• Proven experience in a GCP environment.
• Working knowledge of In-Vitro Diagnostic or Medical Device Regulations is advantageous.

Responsibilities

• Ensure compliance during trial activities.
• Conduct independent QA audits of clinical study sites.
• Support quality review of clinical documentation.

Skills

Quality Compliance

GCP Knowledge

Audit Experience

Education

Degree in a relevant subject

Job description

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.