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: Competitive salary of £41,000 with opportunities for international travel.
- Why this job: Be part of impactful clinical research and work in a dynamic, global environment.
- Qualifications: Degree or equivalent experience in a relevant field; GCP knowledge required.
- Other info: Travel opportunities across Europe and the USA included.
The predicted salary is between 34000 - 46000 £ 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).
Senior QA Specialist - Clinical employer: SRG
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 events or webinars to make connections that could lead to valuable insights or referrals.
✨Tip Number 3
Prepare to discuss specific examples of your audit experience and how you've handled compliance issues in past roles. Being able to articulate your problem-solving skills will set you apart from other candidates.
✨Tip Number 4
Show your willingness to travel by researching the company's global operations and expressing your enthusiasm for international collaboration during interviews. This can highlight your adaptability and eagerness to contribute to their global efforts.
We think you need these skills to ace Senior QA Specialist - Clinical
Some tips for your application 🫡
Understand the Role: Read the job description carefully to understand the key responsibilities and qualifications required for the Senior QA Specialist position. Tailor your application to highlight your relevant experience in GCP and clinical trials.
Highlight Relevant Experience: In your CV and cover letter, emphasise your proven experience in a GCP environment. Include specific examples of your work with clinical trials, compliance oversight, and any audit experience you have.
Showcase Your Qualifications: Make sure to mention your degree or equivalent qualifications clearly. If you have knowledge of In-Vitro Diagnostic or Medical Device Regulations, be sure to include that as well, as it could set you apart from other candidates.
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. Mention your willingness to travel internationally, as this is a key aspect of the job.
How to prepare for a job interview at SRG
✨Know Your GCP Inside Out
Make sure you have a solid understanding of Good Clinical Practice (GCP) guidelines. Be prepared to discuss how you've applied these principles in your previous roles, as this will demonstrate your expertise and suitability for the position.
✨Showcase Your Audit Experience
Since audit experience is desirable for this role, be ready to share specific examples of audits you've conducted or participated in. Highlight any challenges you faced and how you overcame them, as this will show your problem-solving skills.
✨Familiarise Yourself with Relevant Regulations
Brush up on In-Vitro Diagnostic and Medical Device Regulations. Being able to discuss these regulations confidently will set you apart from other candidates and show that you're proactive about staying informed in your field.
✨Prepare Questions About Travel Opportunities
Since the role involves international travel, prepare thoughtful questions about the travel aspect. This shows your enthusiasm for the role and helps you gauge if the travel requirements align with your personal circumstances.