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- 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 compliance.
- Benefits: Competitive salary, full-time permanent role, and opportunities for professional growth.
- Why this job: Make a real impact on patient safety and product quality in the pharmaceutical industry.
- Qualifications: Degree in Pharmacy or related field; 4-5+ years as a Qualified Person.
- Other info: Collaborative environment with strong focus on regulatory compliance and quality assurance.
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 Professional (QP) – Pharmaceuticals employer: Confidential
Contact Detail:
Confidential Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Qualified Professional (QP) – Pharmaceuticals
✨Tip Number 1
Network like a pro! Reach out to professionals in the pharmaceuticals field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that Qualified Person role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of UK and EU regulations. We recommend having specific examples ready that showcase your experience with GMP compliance and batch certification. Show them you’re the expert they need!
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. Use our website to find roles that excite you, and tailor your approach to each company’s culture and mission.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. We believe showing genuine interest in the role can set you apart from other candidates.
We think you need these skills to ace Qualified Professional (QP) – Pharmaceuticals
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 pharmaceuticals, GMP knowledge, and any relevant certifications. We want to see how your skills align with the role!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for the QP role. Mention specific experiences that demonstrate your decision-making authority and compliance expertise. Let us know why you’re excited about joining StudySmarter!
Showcase Your Achievements: Don’t just list your responsibilities; showcase your achievements! Use metrics or examples to illustrate how you've ensured compliance and quality in previous roles. We love seeing how you’ve made an impact in your past positions.
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. Plus, it’s super easy!
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 release. Being able to discuss these confidently will show that you're not just familiar with the rules but can also apply them in real-world scenarios.
✨Showcase Your Experience
Prepare specific examples from your past roles where you've successfully managed batch certification or resolved quality issues. This will help demonstrate your hands-on experience and decision-making skills, which are crucial for a Qualified Person.
✨Understand the Company Culture
Research the company’s values and how they align with your own. During the interview, mention how your approach to quality assurance and compliance fits into their culture. This shows that you’re not just looking for any job, but that you’re genuinely interested in being part of their team.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's current challenges in quality compliance or how they handle regulatory changes. This not only shows your interest but also your proactive mindset, which is essential for a role like this.
