Qualified Person (QP) - Sterile Manufacturing
Qualified Person (QP) - Sterile Manufacturing

Qualified Person (QP) - Sterile Manufacturing

Bournemouth Full-Time 48000 - 72000 £ / year (est.) No home office possible
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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 opportunities, and a collaborative work environment.
  • Why this job: Be part of a mission-driven team that impacts healthcare while mentoring future talent.
  • Qualifications: BSc/MSc in Life Sciences and QP qualification required; strong cGMP knowledge essential.
  • Other info: Opportunity to grow your career in a dynamic and supportive setting.

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

Walker Cole International is an exceptional employer, offering a dynamic work environment in the heart of London, where innovation meets compliance in the pharmaceutical sector. Employees benefit from a strong focus on professional development, with opportunities for mentorship and training, fostering a culture of collaboration and continuous improvement. The company's commitment to maintaining high standards of quality and regulatory compliance ensures that you will play a vital role in impactful projects while enjoying the vibrant lifestyle that London has to offer.
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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

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 examples of how you've handled challenges in compliance and quality assurance.

✨Tip Number 4

Showcase your mentoring skills by highlighting any experience you have in training or developing junior staff. This is an important aspect of the role, and demonstrating your ability to lead and support others can set you apart from other candidates.

We think you need these skills to ace Qualified Person (QP) - Sterile Manufacturing

Qualified Person (QP) qualification
Strong knowledge of cGMP regulations
Familiarity with MHRA and EU guidelines
Experience in Quality Management Systems (QMS)
Batch release expertise for clinical trial products
Understanding of Corrective and Preventative Action (CAPA)
Ability to mentor and train junior staff
Collaboration skills with internal and external stakeholders
Attention to detail in compliance activities
Analytical skills for quality assurance processes
Knowledge of Pharmaceutical Quality Systems (PQS)
Experience with eQMS systems
Operational knowledge of Investigational Medicinal Products (IMP)
Understanding of Good Clinical Practice (GCP)

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 background aligns with the responsibilities outlined in the job description. Mention specific experiences that demonstrate your ability to maintain and improve QMS.

Highlight Relevant Skills: When detailing your experience, focus on skills related to Quality Assurance, batch release activities, and collaboration with stakeholders. Use keywords from the job description to ensure your application stands out.

Proofread Your Application: Before submitting, carefully proofread your CV and cover letter 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. Being able to discuss these in detail will show your expertise and readiness for the role.

✨Demonstrate Your QMS Knowledge

Prepare to talk about your experience with Quality Management Systems. Highlight any improvements you've made in previous roles and how they align with compliance strategies.

✨Showcase Your Mentoring Skills

Since mentoring junior staff is part of the job, be ready to share examples of how you've supported others in their development. This will demonstrate your leadership qualities.

✨Engage with Stakeholders

Discuss your experience collaborating with both internal and external stakeholders. Provide examples of how you’ve effectively communicated and ensured oversight in QA functions.

Qualified Person (QP) - Sterile Manufacturing
Walker Cole International
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  • Qualified Person (QP) - Sterile Manufacturing

    Bournemouth
    Full-Time
    48000 - 72000 £ / year (est.)

    Application deadline: 2027-04-30

  • W

    Walker Cole International

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