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- Tasks: Ensure quality management and oversee batch release for clinical trial products.
- Company: Join a leading Pharmaceutical company in London focused on innovation and quality.
- Benefits: Enjoy competitive pay, professional development opportunities, and a collaborative work environment.
- Why this job: Be part of a vital role in healthcare, impacting patient lives through quality assurance.
- Qualifications: BSc/MSc in Life Sciences and QP qualification required; strong cGMP knowledge essential.
- Other info: Opportunity to mentor junior staff and grow within a dynamic team.
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 and knowledge during any interviews or discussions.
✨Tip Number 3
Consider reaching out to current employees at the company through platforms like LinkedIn. Ask them about their experiences and any insights they can share about the company culture and expectations for the Qualified Person role.
✨Tip Number 4
Prepare to discuss your mentoring experience during interviews. Highlight how you've helped junior staff develop their skills, as this is a key responsibility of the role and shows your leadership capabilities.
We think you need these skills to ace Qualified Person (QP) - Sterile Manufacturing
Some tips for your application 🫡
Understand the Role: Familiarise yourself with the responsibilities of a Qualified Person in sterile manufacturing. Highlight your experience with QMS, batch release activities, and compliance with cGMP regulations in your application.
Tailor Your CV: Ensure your CV reflects your qualifications, particularly your BSc/MSc in Life Sciences and your QP qualification. Emphasise relevant experience in Quality Assurance and any specific projects that demonstrate your expertise in cGMP and regulatory standards.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the pharmaceutical industry and your commitment to quality assurance. Mention your ability to mentor junior staff and collaborate with stakeholders, as these are key aspects of the role.
Highlight Relevant Skills: In your application, make sure to mention your strong knowledge of MHRA and EU guidelines, as well as your experience with CAPA and eQMS. Use specific examples to illustrate how you've applied these skills in previous roles.
How to prepare for a job interview at Walker Cole International
✨Know Your Regulations
Familiarise yourself with cGMP regulations and the specific guidelines from 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
Emphasise your ability to work with both internal and external stakeholders. Prepare examples of successful collaborations that led to improved QA functions, showcasing your teamwork and communication skills.
✨Mentorship Matters
Discuss your experience in mentoring junior staff. Share specific instances where you helped others develop their skills, as this reflects your leadership qualities and commitment to team growth.
