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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 patient safety.
- Benefits: Full-time permanent role with competitive salary and professional growth opportunities.
- Why this job: Make a real impact on public health by ensuring product quality and compliance.
- Qualifications: Degree in Pharmacy, Chemistry, or Biology; 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, Deviations, CAPAs, Change Controls, Risk Assessments, 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
Eligibility
- 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
Key Competencies
- 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
Work Environment
Based at a manufacturing site or corporate quality office. Close collaboration with QA, Manufacturing, Regulatory Affairs, and Supply Chain teams. Reports into UK Quality Leadership.
Qualified Person (QP) – Pharmaceuticals employer: Confidential
Contact Detail:
Confidential Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Qualified Person (QP) – Pharmaceuticals
✨Network Like a Pro
Get out there and connect with people in the industry! Attend events, join relevant groups on LinkedIn, and don’t be shy about reaching out to professionals. You never know who might have the inside scoop on job openings or can refer you directly.
✨Ace the Interview
Prepare for your interviews by researching the company and practising common questions. Think about how your experience as a Qualified Person aligns with their needs. Show them you’re not just a fit on paper but also a great cultural match!
✨Follow Up
After an interview, send a quick thank-you email to express your appreciation for the opportunity. It’s a simple gesture that keeps you fresh in their minds and shows your enthusiasm for the role.
✨Apply Through Our Website
Don’t forget to check out our website for the latest job openings! Applying directly through us can sometimes give you an edge, as we love seeing candidates who are proactive and engaged with our brand.
We think you need these skills to ace Qualified Person (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 passionate about quality assurance in pharmaceuticals and how your experience makes you the perfect fit for our team. Keep it engaging and personal!
Showcase Relevant Experience: When detailing your work history, emphasise your experience with batch certification, regulatory compliance, and quality systems. We’re looking for specific examples that demonstrate your expertise and decision-making skills.
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team at StudySmarter!
How to prepare for a job interview at Confidential
✨Know Your Regulations
Make sure you brush up on UK and EU GMP regulations before the interview. Being able to discuss specific directives, like Directive 2001/83/EC, will show that you’re not just familiar with the rules but can also apply them in practice.
✨Showcase Your Experience
Prepare to share concrete examples from your past roles where you’ve successfully certified batches or resolved quality issues. Use the STAR method (Situation, Task, Action, Result) to structure your answers and highlight your decision-making authority.
✨Understand the Company’s Quality Culture
Research the company’s approach to quality assurance and compliance. Be ready to discuss how you can contribute to their existing systems and what improvements you might suggest based on your experience in large pharmaceutical organisations.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's quality governance and regulatory processes. This shows your genuine interest in the role and helps you assess if the company aligns with your professional values and expectations.
