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For Companies At a Glance
- Tasks: Ensure quality and compliance in clinical trials while supporting global diagnostic testing.
- Company: Join an innovative company advancing life sciences and healthcare research worldwide.
- Benefits: Enjoy opportunities for international travel and a competitive salary of £41,000.
- Why this job: Be part of a mission-driven team making a real impact in healthcare and diagnostics.
- Qualifications: Degree or equivalent experience in a relevant field; GCP knowledge is essential.
- Other info: Travel to sites across Europe and the USA is required.
The predicted salary is between 41000 - 41000 £ per year.
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 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).
Contact Detail:
SRG Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior QA Specialist - Clinical
✨Tip Number 1
Familiarise yourself with Good Clinical Practice (GCP) guidelines and regulations. Understanding these will not only help you in interviews but also demonstrate your commitment to quality assurance in clinical trials.
✨Tip Number 2
Network with professionals in the clinical QA field, especially those who have experience with in-vitro diagnostics or medical devices. Attend industry conferences or webinars to make connections that could lead to job opportunities.
✨Tip Number 3
Prepare for potential travel by researching clinical trial sites in Europe and the USA. Showing that you are proactive and knowledgeable about the locations can set you apart from other candidates.
✨Tip Number 4
Stay updated on the latest trends and technologies in life sciences and healthcare research. Being well-informed will allow you to engage in meaningful conversations during interviews and showcase your passion for the field.
We think you need these skills to ace Senior QA Specialist - Clinical
Some tips for your application 🫡
Understand the Role: Read the job description thoroughly to grasp the key responsibilities and qualifications required for the Senior QA Specialist position. Tailor your application to highlight how your experience aligns with their needs.
Highlight Relevant Experience: Emphasise your GCP experience and any relevant qualifications in your CV and cover letter. Provide specific examples of your work in clinical trials, compliance oversight, and any audit experience you possess.
Showcase Your Skills: Mention your knowledge of In-Vitro Diagnostic or Medical Device Regulations, as well as your ability to travel internationally. This will demonstrate your suitability for the role and willingness to meet the job's demands.
Craft a Strong Cover Letter: Write a compelling cover letter that not only summarises your qualifications but also expresses your enthusiasm for the role and the company. Make sure to address how you can contribute to their innovative work in life sciences and healthcare research.
How to prepare for a job interview at SRG
✨Understand GCP Regulations
Make sure you have a solid grasp of Good Clinical Practice (GCP) regulations. Be prepared to discuss how your experience aligns with these standards and how you've ensured compliance in previous roles.
✨Showcase Your Audit Experience
Highlight any audit experience you have, especially in clinical settings. Be ready to share specific examples of audits you've conducted or participated in, and the outcomes of those audits.
✨Demonstrate Your Teamwork Skills
Since you'll be working closely with the Clinical Affairs team, emphasise your ability to collaborate effectively. Share examples of how you've worked with cross-functional teams to resolve issues or improve processes.
✨Prepare for Travel Questions
As the role involves international travel, be prepared to discuss your willingness and availability to travel. You might want to mention any previous travel experiences related to work and how you managed them.
