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- Tasks: Ensure compliance and quality in medicinal product manufacturing and batch certification.
- Company: VBeyond Corporation, a leader in pharmaceutical quality assurance.
- Benefits: Competitive salary, career growth, and a chance to impact patient safety.
- Why this job: Be the key authority ensuring safe medicines reach patients across the UK and EU.
- Qualifications: Degree in pharmacy, chemistry, or biology; 4-5 years as a Qualified Person.
- Other info: Dynamic role with opportunities to work closely with production and regulatory teams.
The predicted salary is between 48000 - 72000 £ per year.
The Qualified Person (QP) will be responsible for ensuring that each batch of medicinal product is manufactured and checked in compliance with applicable laws, EU/UK regulations, and Marketing Authorization requirements prior to release. The QP will act as the primary authority for quality, compliance, and batch certification, ensuring patient safety and regulatory adherence across UK/EU markets.
Accountability Clusters & Major Activities
- Manufacturing Oversight & Compliance
- Monitor manufacturing of batches to ensure overall manufacturing compliance.
- Drive manufacturing processes as per national laws of the respective countries, and/or European Union regulations.
- Ensure full compliance with the requirements of the Marketing.
- Batch Specifications, Import & Product Release Management
- Schedule and manage overall specifications as described in the guidelines for each batch imported into the EU.
- Drive and monitor quantitative and qualitative analysis of products imported from outside the EU in accordance with Marketing Authorization requirements.
- Quantitative & Release Activities
- Review and evaluate release of necessary certificates as per EU guidelines.
- Plan, implement, and track release of required reference retained samples for each batch.
- Monitor validation of manufacturing and quality control testing processes.
- Help resolve product issues for the UK/EU market by working with cross-functional teams for both IH products and IL products.
- Documentation, Registers & Record Maintenance
- Implement and maintain Registers or equivalent documentation covering all operations.
- Implement and track certifications for product release or sale within the EU.
- Maintain records including but not limited to:
- Quality Management Review (QMR)
- Annual Product Review (APR)
- Deviations
- CAPAs
- Risk Assessments
- Change Controls
- Self-Inspections
- Evaluate validation of Quality Agreements with third parties in line with GMP compliance.
- Drive, monitor, and control the company Quality System in compliance with regulatory and legal frameworks.
- Act as the single point of contact for:
- Quality issues
- Compliance questions
- Product recalls
- Corporate Quality Policies
- Compliance procedures
- Local regulatory requirements
- Review, evaluate, and guide management on manufacturing and quality factors affecting product quality and patient safety.
- Stay abreast of developments in:
- Legal environments affecting the company
- EU and UK regulatory changes
- Manufacturing line approvals
- Product approvals
- Act as Qualified Person for Cipla Holding B.V. Post QP application approval.
Required Qualifications
- Must be eligible to act as a Qualified Person under UK law (Directive 2001/83/EC).
- Typically holds a degree in:
- Pharmacy
- Chemistry
- Biology
- or related discipline.
Experience Requirements
- At least 4–5 years functioning in a formal QP role.
- Proven experience in GMP-regulated pharmaceutical environments.
- Experience with UK/EU regulatory authorities and inspections preferred.
Skills & Attributes
- Strong understanding of GMP and pharmaceutical regulations.
- Excellent decision-making and problem-solving abilities.
- High attention to detail and strong professional integrity.
- Strong leadership, communication, and stakeholder management skills.
Work Environment
- Primarily based at manufacturing site or corporate quality office.
- Works closely with:
- Production
- Quality Assurance
- Regulatory Affairs
- Supply Chain
Must-Haves
- 4–5 years minimum as a Qualified Person
- Degree in pharmacy, chemistry, biology, or related field
- Eligibility as QP under UK law
- Strong GMP and regulatory knowledge
- Experience in large pharmaceutical companies
- Extensive pharmaceutical manufacturing and QA experience
Qualified Person (QP) - VBeyond Corporation employer: Jobster
Contact Detail:
Jobster Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Qualified Person (QP) - VBeyond Corporation
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those who have experience as a Qualified Person. They can provide insights and may even refer you to open positions.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GMP and EU/UK regulations. Be ready to discuss how your experience aligns with the responsibilities of the QP role at VBeyond Corporation.
✨Tip Number 3
Showcase your problem-solving skills during interviews. Think of examples from your past roles where you successfully navigated compliance issues or improved quality systems.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed and shows your genuine interest in joining the team at VBeyond Corporation.
We think you need these skills to ace Qualified Person (QP) - VBeyond Corporation
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Qualified Person role. Highlight your experience in pharmaceutical manufacturing and quality assurance, and don’t forget to mention any relevant qualifications that make you eligible under UK law.
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 position. Mention specific experiences that align with the job description, especially your knowledge of GMP and regulatory compliance.
Showcase Your Attention to Detail: In the pharmaceutical industry, attention to detail is crucial. Make sure your application is free from typos and errors. This not only reflects your professionalism but also your commitment to quality, which is key for a QP.
Apply Through Our Website: We encourage you to apply through our website for the best chance of getting noticed. It’s straightforward and ensures your application goes directly to the right team. Plus, we love seeing applications come in through our platform!
How to prepare for a job interview at Jobster
✨Know Your Regulations
Make sure you brush up on the latest EU/UK regulations and GMP guidelines. Being able to discuss these in detail will show that you're not just familiar with the rules, but that you can apply them practically in a manufacturing environment.
✨Showcase Your Experience
Prepare specific examples from your past roles where you've ensured compliance or resolved quality issues. Highlighting your hands-on experience in pharmaceutical manufacturing will demonstrate your capability as a Qualified Person.
✨Understand the Company’s Quality Systems
Research VBeyond Corporation's quality systems and any recent developments in their operations. This knowledge will help you tailor your answers and show that you're genuinely interested in how you can contribute to their success.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's approach to quality assurance and regulatory compliance. This not only shows your interest but also gives you a chance to assess if the company aligns with your professional values and goals.
