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- Tasks: Ensure quality and compliance of sterile pharmaceutical products as a Qualified Person.
- Company: Join a leading pharmaceutical company committed to excellence in quality assurance.
- Benefits: Enjoy a permanent position with opportunities for professional growth and development.
- Why this job: Be part of a dynamic team making a real impact in healthcare through quality leadership.
- Qualifications: Must be a legally recognized Qualified Person with experience in sterile manufacturing.
- Other info: Stay updated on regulatory changes and lead initiatives for continuous improvement.
The predicted salary is between 36000 - 60000 £ per year.
Job Description
Job Title: Qualified Person (QP)
Location: Oxford, England
Employment Type: Permanent
Job Description:
An exciting opportunity has arisen for a Qualified Person (QP) to join our client’s Quality team based in Oxford. This role is pivotal in ensuring the batch certification, regulatory compliance, and quality assurance of sterile pharmaceutical products, adhering to Good Manufacturing Practice (GMP).
Key Responsibilities:
- Perform duties as a Qualified Person (QP) under EU GMP regulations for the release of sterile products.
- Ensure full regulatory compliance with MHRA, EU GMP, and company policies.
- Oversee and enhance Quality Management Systems (QMS) to ensure continuous improvement.
- Manage deviations, CAPA, change controls, and regulatory audits to maintain high-quality standards.
- Work closely with manufacturing, regulatory, and supply chain teams to ensure smooth and compliant operations.
- Provide quality leadership, guidance, and training to the team to uphold GMP compliance.
- Keep up to date with regulatory developments and ensure best practices are implemented.
Key Requirements:
- Legally recognized as a Qualified Person (QP) under EU Directive 2001/83/EC.
- Demonstrable experience in sterile manufacturing and batch release.
- Strong understanding of GMP, QMS, regulatory compliance, and pharmaceutical quality assurance.
- Ability to manage regulatory inspections, audits, and continuous quality improvement initiatives.
- Excellent problem-solving, communication, and leadership skills.
Qualified Person (QP) employer: Albion Rye Associates
Contact Detail:
Albion Rye Associates Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Qualified Person (QP)
✨Tip Number 1
Make sure to highlight your experience with EU GMP regulations and batch release processes during the interview. Be prepared to discuss specific examples of how you've ensured compliance in previous roles.
✨Tip Number 2
Familiarize yourself with the latest regulatory developments and best practices in pharmaceutical quality assurance. This knowledge will not only impress your interviewers but also demonstrate your commitment to continuous improvement.
✨Tip Number 3
Showcase your leadership skills by discussing how you've guided teams through audits or inspections. Providing concrete examples of your problem-solving abilities in high-pressure situations can set you apart from other candidates.
✨Tip Number 4
Network with professionals in the pharmaceutical industry, especially those who work in quality assurance. Engaging with others in the field can provide valuable insights and potentially lead to referrals for the position.
We think you need these skills to ace Qualified Person (QP)
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Qualified Person (QP) position. Understand the key responsibilities and requirements, especially regarding EU GMP regulations and quality assurance.
Highlight Relevant Experience: In your application, emphasize your experience in sterile manufacturing and batch release. Provide specific examples of how you've ensured regulatory compliance and managed quality systems in previous roles.
Showcase Your Skills: Clearly outline your problem-solving, communication, and leadership skills in your CV and cover letter. Use concrete examples to demonstrate how these skills have contributed to successful outcomes in your past positions.
Tailor Your Application: Customize your CV and cover letter to align with the specific requirements of the QP role. Mention your legal recognition as a Qualified Person and any relevant certifications or training that support your candidacy.
How to prepare for a job interview at Albion Rye Associates
✨Show Your Regulatory Knowledge
Make sure to demonstrate your understanding of EU GMP regulations and how they apply to the role of a Qualified Person. Be prepared to discuss specific examples from your experience that highlight your compliance with these standards.
✨Highlight Your Experience in Sterile Manufacturing
Discuss your previous roles in sterile manufacturing and batch release. Provide concrete examples of how you ensured quality assurance and regulatory compliance in those positions.
✨Emphasize Problem-Solving Skills
Prepare to share instances where you successfully managed deviations, CAPA, or change controls. This will showcase your ability to handle challenges and maintain high-quality standards.
✨Demonstrate Leadership and Team Collaboration
Talk about your experience in providing guidance and training to teams. Highlight how you have worked closely with cross-functional teams to ensure smooth operations and compliance, as this is crucial for the role.
