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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 compliance.
- Benefits: Enjoy a collaborative work environment with opportunities for mentorship and professional growth.
- Why this job: Be part of a vital role in healthcare, impacting patient safety and product quality.
- Qualifications: Must have a BSc/MSc in Life Sciences and QP qualification under EU directives.
- Other info: Ideal for those passionate about quality assurance in the pharmaceutical industry.
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 help you in interviews but also demonstrate your commitment to maintaining high standards in quality assurance.
✨Tip Number 3
Consider reaching out to current employees at the company to gain insights into their culture and expectations. This can provide you with valuable information that can be used to tailor your approach during the interview process.
✨Tip Number 4
Prepare to discuss your experience with batch release activities and how you've contributed to improving QMS in previous roles. Be ready to share specific examples that highlight your expertise and problem-solving skills in quality assurance.
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 and experience relevant to the Qualified Person role. Emphasise your BSc/MSc in Life Sciences, QP qualification, and any specific experience with cGMP regulations and batch release activities.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for quality assurance in the pharmaceutical industry. Mention your experience with QMS and compliance strategies, and how you can contribute to the company's goals.
Highlight Relevant Skills: In your application, clearly outline your knowledge of MHRA and EU guidelines, as well as your experience in mentoring junior staff. This will demonstrate your capability to fulfil the responsibilities of the role.
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 from MHRA and EU. Be prepared to discuss how these regulations impact quality management systems and batch release processes.
✨Showcase Your Experience
Prepare examples from your past roles that demonstrate your experience in maintaining and improving QMS. Highlight any specific projects where you successfully ensured compliance with regulatory standards.
✨Collaboration is Key
Emphasise your ability to work with both internal and external stakeholders. Be ready to discuss how you've collaborated in the past to oversee clinical QA functions and how you can bring that experience to the new role.
✨Mentorship Matters
Since mentoring junior staff is part of the role, think about your previous experiences in training or guiding others. Share specific instances where you helped someone develop their skills or knowledge in the field.
