At a Glance
- Tasks: Ensure compliance and quality assurance for sterile pharmaceutical products.
- Company: Join a leading Quality team in Stoke-on-Trent focused on pharmaceutical excellence.
- Benefits: Enjoy a permanent position with opportunities for professional growth and development.
- Why this job: Be a key player in maintaining high standards and improving quality processes.
- Qualifications: Must be legally eligible as a Qualified Person with strong GMP experience.
- Other info: Collaborate with cross-functional teams and lead the QA team to success.
The predicted salary is between 36000 - 60000 £ per year.
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 in sterile manufacturing environments during the interview. Be prepared to discuss specific examples of how you've ensured compliance with GMP and other regulatory standards.
✨Tip Number 2
Familiarize yourself with the latest updates in EU regulations and GMP guidelines. Showing that you are proactive about staying informed can set you apart from other candidates.
✨Tip Number 3
Demonstrate your leadership skills by discussing any previous experiences where you led a QA team or implemented quality improvement initiatives. This will showcase your ability to enhance operational efficiency.
✨Tip Number 4
Prepare to discuss your approach to conducting audits and risk assessments. Providing concrete examples of how you've handled deviations or non-compliance issues will illustrate your problem-solving capabilities.
We think you need these skills to ace Qualified Person (QP)
Some tips for your application 🫡
Understand the Role: Make sure you fully understand the responsibilities of a Qualified Person (QP) as outlined in the job description. Highlight your relevant experience in sterile manufacturing and compliance with GMP regulations.
Tailor Your CV: Customize your CV to emphasize your experience with Quality Management Systems (QMS), audits, and regulatory compliance. Use specific examples that demonstrate your problem-solving skills and leadership abilities.
Craft a Strong Cover Letter: Write a compelling cover letter that connects your background to the key requirements of the role. Discuss your experience in managing quality assurance processes and how you can contribute to the company's goals.
Proofread Your Application: Before submitting, carefully proofread your application materials for any errors or inconsistencies. A polished application reflects your attention to detail, which is crucial for a QP role.
How to prepare for a job interview at Albion Rye Associates
✨Show Your GMP Knowledge
Make sure to highlight your understanding of Good Manufacturing Practice (GMP) during the interview. Be prepared to discuss specific examples of how you've ensured compliance in previous roles, as this is crucial for the Qualified Person position.
✨Demonstrate Leadership Skills
Since the role involves providing leadership and training to the QA team, be ready to share experiences where you successfully led a team or improved processes. This will showcase your ability to enhance compliance and operational efficiency.
✨Prepare for Technical Questions
Expect technical questions related to Quality Management Systems (QMS), audits, and regulatory inspections. Brush up on your knowledge in these areas and be ready to explain how you've handled similar situations in the past.
✨Emphasize Cross-Functional Collaboration
The role requires collaboration with various teams. Prepare examples that demonstrate your ability to work cross-functionally, especially with production, regulatory, and R&D teams, to ensure quality standards are met.