At a Glance
- Tasks: Ensure compliance and quality of medicinal products before release.
- Company: VBeyond Corporation, a leader in pharmaceutical manufacturing.
- Benefits: Competitive salary, career growth, and a dynamic work environment.
- Why this job: Make a real impact on patient safety and regulatory compliance.
- Qualifications: Degree in pharmacy, chemistry, or biology; 4-5 years as a Qualified Person.
- Other info: Collaborate with cross-functional teams in a fast-paced setting.
The predicted salary is between 36000 - 60000 Β£ 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.
- 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 4β5 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
- 4β5 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 in London employer: Jobster
Contact Detail:
Jobster Recruiting Team
StudySmarter Expert Advice π€«
We think this is how you could land Qualified Person (QP) - VBeyond Corporation in London
β¨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 roles. A friendly chat can lead to insider info about job openings that might not even be advertised yet.
β¨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GMP and EU/UK regulations. We all know that confidence is key, so practice answering common QP-related questions with a mate or in front of the mirror to nail that interview!
β¨Tip Number 3
Donβt forget to showcase your experience! When you get the chance to chat with potential employers, highlight your past roles and how they align with the responsibilities of a Qualified Person. Make it clear how your skills can ensure patient safety and compliance.
β¨Tip Number 4
Apply through our website! Itβs super easy and gives you a direct line to the hiring team. Plus, it shows youβre genuinely interested in joining us at VBeyond Corporation. Donβt miss out on that opportunity!
We think you need these skills to ace Qualified Person (QP) - VBeyond Corporation in London
Some tips for your application π«‘
Tailor Your Application: Make sure to customise your CV and cover letter for the Qualified Person role. Highlight your relevant experience in pharmaceutical manufacturing and quality assurance, and donβt forget to mention your understanding of GMP and regulatory requirements!
Showcase Your Experience: We want to see your journey! Detail your 4-5 years of experience as a Qualified Person and any specific projects or challenges you've tackled. This helps us understand how you can contribute to our team.
Be Clear and Concise: Keep your application straightforward and to the point. Use bullet points where possible to make it easy for us to read through your qualifications and experiences without getting lost in lengthy paragraphs.
Apply Through Our Website: Donβt forget to submit your application through our website! Itβs the best way for us to receive your details and ensures youβre considered for the role. We canβt wait to hear from you!
How to prepare for a job interview at Jobster
β¨Know Your Regulations
Make sure you brush up on the latest EU/UK regulations and GMP guidelines. Being able to discuss these confidently will show that you're not just familiar with the rules, but that you can apply them in real-world scenarios.
β¨Showcase Your Experience
Prepare specific examples from your past roles where you've ensured compliance or resolved quality issues. Use the STAR method (Situation, Task, Action, Result) to structure your answers and highlight your problem-solving skills.
β¨Understand the Companyβs Quality Systems
Research VBeyond Corporation's quality systems and any recent news about their operations. This will help you tailor your responses and demonstrate your genuine interest in how they maintain compliance and patient safety.
β¨Ask Insightful Questions
Prepare thoughtful questions about the company's approach to regulatory changes or how they handle product recalls. This shows that you're proactive and engaged, and it gives you a chance to assess if the company aligns with your values.