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For Companies At a Glance
- Tasks: Ensure compliance and oversee batch release for clinical trial products.
- Company: Join a leading Pharmaceutical company in London, dedicated to quality and innovation.
- Benefits: Enjoy competitive pay, professional development, and a collaborative work environment.
- Why this job: Make a real impact in healthcare while mentoring the next generation of professionals.
- Qualifications: BSc/MSc in Life Sciences and QP qualification required.
- Other info: Opportunity to work with cutting-edge technologies and contribute to vital clinical trials.
The predicted salary is between 48000 - 72000 £ per year.
Walker Cole International is searching for a Qualified Person to join a Pharmaceutical company based in London. As the Qualified Person you will be a key part of ensuring maintenance of the company's QMS and performing batch release activities. You will be responsible for:
- Developing, maintaining and improving the QMS & Compliance strategy to ensure they meet cGMP regulations and regulatory standards.
- Carrying out the QP batch release of a range of clinical trial products.
- Collaborating with both internal and external stakeholders to have an oversight of all clinical QA functions and activities.
- Mentoring and assisting junior members of staff with their own development and training.
The successful candidate will have:
- A BSc/MSc (or equivalent) in a Life Sciences discipline.
- Qualified Person (QP) qualification under the provision of the Directive 2001/20/EC and 2001/83/EC.
- Strong knowledge of cGMP, MHRA and EU guidelines.
Qualified Person (QP) - Sterile Manufacturing employer: Walker Cole International
Contact Detail:
Walker Cole International Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Qualified Person (QP) - Sterile Manufacturing
✨Tip Number 1
Network with professionals in the pharmaceutical industry, especially those who are already working as Qualified Persons. Attend industry conferences or seminars to meet potential colleagues and learn about the latest trends in QMS and compliance.
✨Tip Number 2
Familiarise yourself with the specific cGMP regulations and guidelines relevant to the role. This will not only boost your confidence but also demonstrate your commitment to maintaining high standards in quality assurance during interviews.
✨Tip Number 3
Prepare to discuss your experience with batch release activities and how you've successfully collaborated with stakeholders in previous roles. Real-life examples will help you stand out and show that you can handle the responsibilities of the position.
✨Tip Number 4
Consider obtaining additional certifications or training related to Quality Management Systems or regulatory compliance. This can enhance your qualifications and make you a more attractive candidate for the Qualified Person role.
We think you need these skills to ace Qualified Person (QP) - Sterile Manufacturing
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your qualifications, especially your BSc/MSc in Life Sciences and your QP qualification. Emphasise your experience with cGMP regulations and any relevant QA roles you've held.
Craft a Strong Cover Letter: In your cover letter, explain why you are passionate about the role of Qualified Person and how your skills align with the responsibilities outlined in the job description. Mention your experience with batch release activities and collaboration with stakeholders.
Showcase Relevant Experience: When detailing your work history, focus on specific examples that demonstrate your knowledge of QMS, compliance strategies, and mentoring junior staff. Use metrics or outcomes to illustrate your impact in previous roles.
Proofread Your Application: Before submitting, carefully proofread your application for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial in the pharmaceutical industry.
How to prepare for a job interview at Walker Cole International
✨Know Your Regulations
Familiarise yourself with cGMP regulations and the specific guidelines set by MHRA and EU. Be prepared to discuss how you have applied these in your previous roles, as this will demonstrate your expertise and understanding of the industry standards.
✨Showcase Your QMS Experience
Highlight your experience in developing and maintaining Quality Management Systems. Be ready to provide examples of how you've improved compliance strategies in past positions, as this is crucial for the role.
✨Collaboration is Key
Prepare to discuss your experience working with both internal and external stakeholders. Share specific instances where your collaboration led to successful outcomes in clinical QA functions, as teamwork is essential in this position.
✨Mentorship Matters
Since mentoring junior staff is part of the role, think about your past experiences in training or guiding others. Be ready to share how you approach mentorship and the impact it has had on team development.
