Senior QA Specialist - Clinical

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

Job summary

Join a forward-thinking company as a QA Officer in Clinical, where your expertise in GCP compliance will play a crucial role in supporting global healthcare advancements. This position offers the chance to oversee quality and compliance during clinical activities while collaborating with a dedicated Clinical Affairs team. You'll be involved in reviewing critical documentation, conducting audits, and ensuring adherence to regulatory standards. With opportunities to travel across Europe and the USA, this role promises a dynamic work environment where your contributions will significantly impact life science research.

Qualifications

• Degree or equivalent experience in a relevant subject.
• Proven experience in a GCP environment.

Responsibilities

• Ensure compliance during trial activities and manage deviations.
• Conduct independent QA audits of clinical study sites.

Skills

GCP Compliance

Quality Assurance Audits

Regulatory Knowledge

Clinical Documentation Review

Education

Degree in Life Sciences

Equivalent Experience

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.