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For Companies At a Glance
- Tasks: Ensure compliance of medicinal products with UK and EU regulations and certify batches for market release.
- Company: Leading pharmaceutical company committed to quality and regulatory excellence.
- Benefits: Competitive salary, full-time role, and opportunities for professional growth.
- Why this job: Be the key player in ensuring patient safety and product quality in a dynamic environment.
- Qualifications: Degree in Pharmacy or related field; 4-5+ years as a Qualified Person.
- Other info: Join a collaborative team focused on innovation and compliance in pharmaceuticals.
The predicted salary is between 36000 - 60000 £ per year.
Location: London, United Kingdom (Onsite)
Work Arrangement: Onsite – Plant / Quality Office (No remote work)
Work Schedule: Standard business hours (Full onsite presence required)
Employment Type: Full-Time | Permanent
Role Overview
We are seeking an experienced Qualified Person (QP) to ensure that medicinal products released to the UK and EU markets comply with UK law, EU Directives, GMP requirements, and Marketing Authorisation conditions. The QP will act as the single accountable authority for batch certification, quality compliance, and regulatory readiness, working closely with Manufacturing, Quality Assurance, Regulatory Affairs, and Supply Chain teams.
Key Responsibilities
- Batch Certification & Manufacturing Compliance
- Certify batches in accordance with UK law, EU GMP, and Directive 2001/83/EC
- Ensure manufacturing activities comply with Marketing Authorisation requirements
- Act as the final decision-maker for batch release to the UK/EU market
- Importation & Product Release (EU/UK)
- Schedule and manage quantitative and qualitative analysis of imported products
- Review and approve Certificates of Analysis and batch documentation
- Ensure retention samples and reference samples are stored and tracked per regulations
- Monitor validation status of manufacturing and QC testing processes
- Support resolution of product quality issues for UK/EU markets through cross-functional collaboration
- Quality Systems & Documentation
- Maintain and oversee QP Registers or equivalent systems for batch certification
- Review and maintain documentation including: Annual Product Reviews (APR), Quality Management Reviews, Self-inspection reports
- Ensure Quality Agreements with third parties comply with GMP expectations
- Regulatory Compliance & Quality Governance
- Act as the primary point of contact for quality, compliance, recalls, and inspections
- Ensure corporate quality policies and local regulatory requirements are fully implemented
- Drive SOP development and maintenance aligned with current UK/EU guidelines
- Plan and monitor GMP and SOP training for relevant employees
- Regulatory Intelligence & Management Advisory
- Stay current with changes in UK, EU, and MHRA regulatory frameworks
- Advise senior management on quality, compliance, and patient safety risks
- Support interactions with MHRA for manufacturing lines and product approvals
- Qualified Person Accountability
- Act as Named Qualified Person following QP approval
- Perform all statutory QP duties in compliance with UK and EU regulations
Required Qualifications
Education
- Degree in Pharmacy, Chemistry, Biology, or a related scientific discipline
- Must be eligible to act as a Qualified Person under UK law (Directive 2001/83/EC)
Experience
- 4–5+ years of experience acting as a Qualified Person (QP)
- Strong background in pharmaceutical manufacturing and quality assurance
- Experience working within large or complex pharmaceutical organizations
- Solid understanding of GMP, EU regulations, and batch release requirements
- Expert knowledge of EU & UK GMP regulations
- Strong decision-making authority and integrity
- High attention to detail and risk awareness
- Excellent communication and stakeholder management skills
- Ability to work independently in a highly accountable role
- Based at a manufacturing site or corporate quality office
- Close collaboration with QA, Manufacturing, Regulatory Affairs, and Supply Chain teams
Qualified Person/ Licensed pharmacist employer: Confidential
Contact Detail:
Confidential Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Qualified Person/ Licensed pharmacist
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those who work in quality assurance or regulatory affairs. A friendly chat can lead to insider info about job openings that might not even be advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of UK and EU regulations. Be ready to discuss how your experience aligns with the responsibilities of a Qualified Person. We want you to showcase your expertise and decision-making skills!
✨Tip Number 3
Don’t forget to follow up after interviews! A quick thank-you email can keep you fresh in the interviewer's mind. Plus, it shows your enthusiasm for the role and your professionalism.
✨Tip Number 4
Apply through our website for the best chance at landing that Qualified Person role. We’re always on the lookout for passionate candidates who are ready to make an impact in the pharmaceutical field!
We think you need these skills to ace Qualified Person/ Licensed pharmacist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to highlight your experience as a Qualified Person. Focus on your background in pharmaceutical manufacturing, quality assurance, and any relevant regulatory compliance work you've done.
Craft a Compelling Cover Letter: Your cover letter should tell us why you're the perfect fit for this role. Mention specific experiences that align with the key responsibilities listed in the job description, especially around batch certification and quality compliance.
Showcase Your Qualifications: Don’t forget to clearly outline your qualifications, especially your degree in Pharmacy or related fields. Highlight your eligibility to act as a Qualified Person under UK law, as this is crucial for us.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss out on any important updates!
How to prepare for a job interview at Confidential
✨Know Your Regulations
Make sure you brush up on UK and EU regulations, especially those related to GMP and batch certification. Being able to discuss specific directives like 2001/83/EC will show that you’re not just familiar with the rules but can apply them in practice.
✨Showcase Your Experience
Prepare to share concrete examples from your past roles where you’ve successfully managed batch releases or dealt with quality compliance issues. Highlighting your experience in large pharmaceutical organisations will resonate well with the interviewers.
✨Demonstrate Cross-Functional Collaboration
Since the role involves working closely with various teams, be ready to discuss how you’ve effectively collaborated with Manufacturing, Quality Assurance, and Regulatory Affairs in the past. This will illustrate your ability to work in a team-oriented environment.
✨Ask Insightful Questions
Prepare thoughtful questions about the company’s current challenges in regulatory compliance or quality governance. This shows your genuine interest in the role and helps you gauge if the company aligns with your career goals.
