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- Tasks: Ensure compliance and oversee batch release for clinical trial products.
- Company: Join a leading Pharmaceutical company in London focused on quality and innovation.
- Benefits: Enjoy competitive pay, professional development, and a collaborative work environment.
- Why this job: Be part of a mission-driven team making a real impact in healthcare.
- Qualifications: BSc/MSc in Life Sciences and QP qualification required.
- Other info: Opportunity to mentor junior staff and enhance your career in a dynamic field.
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 discussions with the hiring team.
✨Tip Number 3
Consider reaching out to current or former employees of the company to gain insights into their culture and expectations. This can help you tailor your approach and show that you understand what they value in a Qualified Person.
✨Tip Number 4
Prepare to discuss your experience with batch release activities and how you've contributed to maintaining a Quality Management System in previous roles. Be ready to provide specific examples that highlight your expertise and problem-solving skills.
We think you need these skills to ace Qualified Person (QP) - Sterile Manufacturing
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of a Qualified Person in sterile manufacturing. Familiarise yourself with the company's QMS and compliance strategies to tailor your application accordingly.
Highlight Relevant Qualifications: Clearly state your BSc/MSc in a Life Sciences discipline and your Qualified Person qualification. Emphasise your knowledge of cGMP, MHRA, and EU guidelines, as these are crucial for the role.
Showcase Your Experience: In your CV and cover letter, provide specific examples of your experience with batch release activities and quality assurance functions. Mention any mentoring or training roles you've had, as this aligns with the job's requirements.
Tailor Your Application: Customise your CV and cover letter to reflect the key skills and experiences mentioned in the job description. Use relevant terminology such as 'Quality Management System' and 'Corrective and Preventative Action' to demonstrate your familiarity with the field.
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 these regulations impact your previous work and how you ensure compliance in your role.
✨Showcase Your QMS Experience
Be ready to talk about your experience in developing and maintaining Quality Management Systems. Highlight any specific improvements you've made in past roles that align with the company's goals.
✨Collaboration is Key
Prepare examples of how you've successfully collaborated with both internal and external stakeholders. Emphasise your communication skills and ability to work as part of a team, especially in a clinical QA context.
✨Mentorship Matters
Discuss your experience in mentoring junior staff. Share specific instances where you've helped others develop their skills, as this shows your leadership potential and commitment to team growth.
