Quality assurance specialist

SRG Greater Manchester, England, United Kingdom


Quality Assurance Specialist

SRG Greater Manchester, England, United Kingdom

This range is provided by SRG. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.


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QA Specialist - Clinical

Location: Greater Manchester

About the Role

SRG are recruiting for a QA Officer with GcP experience to join an innovative company whose technologies form an integral part of 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)


Seniority level

* Seniority level

Associate


Employment type

* Employment type

Full-time


Job function

* Job function

Quality Assurance
* Industries

Medical Equipment Manufacturing and Pharmaceutical Manufacturing

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