At a Glance
- Tasks: Ensure quality and compliance in clinical trials while supporting global testing activities.
- Company: Join an innovative company advancing life sciences and healthcare research worldwide.
- Benefits: Enjoy competitive salary, potential travel opportunities, and a dynamic work environment.
- Why this job: Be part of impactful projects that shape healthcare, with a culture of innovation and collaboration.
- Qualifications: Degree in a relevant field or equivalent experience; GCP knowledge is essential.
- Other info: Opportunity to travel across Europe and the USA for site visits.
The predicted salary is between 32800 - 49400 £ 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.
Senior QA Specialist - Clinical employer: Click To Hired
Contact Detail:
Click To Hired 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 join relevant online forums 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 willing to travel 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 knowledgeable about current advancements can give you an edge during discussions with the hiring team.
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 understand the key responsibilities and requirements. Highlight your relevant experience in GCP and any specific knowledge of In-Vitro Diagnostic or Medical Device Regulations.
Tailor Your CV: Customise your CV to reflect your experience in quality assurance within clinical settings. Emphasise your audit experience and any compliance oversight roles you've held, ensuring to align your skills with the job's requirements.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for quality assurance in clinical trials. Mention specific examples of how you've contributed to compliance and quality oversight in previous roles, and express your enthusiasm for the opportunity to work with innovative technologies.
Proofread Your Application: Before submitting, carefully proofread your application materials. Check for spelling and grammatical errors, and ensure that all information is clear and concise. A polished application reflects your attention to detail, which is crucial for a QA role.
How to prepare for a job interview at Click To Hired
✨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 applied them in previous roles.
✨Showcase Your Audit Experience
Highlight any audit experience you have, especially in clinical settings. Be ready to provide examples of audits you've conducted or participated in, and how they contributed to compliance and quality assurance.
✨Familiarise Yourself with the Company
Research the company’s technologies and their impact on life sciences and healthcare. Understanding their mission and recent developments will help you tailor your responses and show genuine interest.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving skills in real-world situations. Think of specific instances where you successfully managed deviations or complaints during clinical trials.