At a Glance
- Tasks: Ensure compliance and quality in pharmaceutical manufacturing as a Qualified Person.
- Company: Leading pharmaceutical manufacturer with a strong focus on quality.
- Benefits: Competitive salary, comprehensive benefits, and a collaborative work environment.
- Other info: Opportunity for career growth and involvement in global manufacturing programmes.
- Why this job: Play a key role in ensuring product safety and quality in a dynamic industry.
- Qualifications: Eligible QP status and experience in GMP pharmaceutical manufacturing required.
The predicted salary is between 50000 - 65000 £ per year.
A leading pharmaceutical manufacturer is seeking an experienced Qualified Person (QP) to join its Quality function. This is an excellent opportunity to play a key role in ensuring products are certified and released in compliance with UK and EU GMP requirements while supporting both commercial and investigational medicinal products. The successful candidate will provide QP oversight across manufacturing operations, contribute to the Pharmaceutical Quality System, and work closely with cross-functional teams to maintain the highest standards of quality and compliance.
Key Responsibilities
- Act as a Qualified Person in accordance with EU GMP Annex 16 and applicable UK legislation.
- Certify commercial and investigational medicinal product batches for release.
- Ensure batches comply with Marketing Authorisations, Product Specifications, GMP requirements and Quality Technical Agreements.
- Review and approve Annual Product Reviews (APRs) and Product Quality Reviews (PQRs).
- Provide QP support to internal project teams and new product initiatives.
- Participate in customer meetings, technical discussions and project reviews.
- Represent Quality during customer audits, regulatory inspections and client visits.
- Review and approve Quality Technical Agreements with customers and external partners.
- Support the development and continuous improvement of the Pharmaceutical Quality System (PQS).
- Review and approve deviations, CAPAs, change controls, investigations and other key quality documentation.
- Contribute to quality risk management activities and continuous improvement initiatives.
- Participate in internal and external audit programmes.
- Maintain current knowledge of GMP regulations, Annex 16 requirements and industry best practices.
Requirements
- Eligible to act as a Qualified Person (QP) in the UK.
- Previous experience performing QP batch certification within a GMP pharmaceutical manufacturing environment.
- Strong knowledge of EU GMP, Annex 16 and pharmaceutical quality systems.
- Experience supporting commercial and/or investigational medicinal products.
- Proven experience reviewing quality documentation including deviations, CAPAs, change controls and investigations.
- Experience participating in regulatory inspections and customer audits.
- Excellent communication and stakeholder management skills.
- Strong attention to detail with a proactive, risk-based approach to quality.
Desirable Experience
- Experience within a Contract Development and Manufacturing Organisation (CDMO).
- Exposure to both commercial and clinical manufacturing.
- Experience reviewing Quality Technical Agreements.
- Broad understanding of pharmaceutical manufacturing operations and cross-functional quality support.
What's on Offer
- Permanent opportunity with a leading pharmaceutical manufacturer.
- High-impact role within an established Quality organisation.
- Exposure to both commercial and investigational products.
- Collaborative environment with opportunities to support global manufacturing programmes.
- Competitive salary and comprehensive benefits package.
Qualified Person in Liverpool employer: Thor
Join a leading pharmaceutical manufacturer in the Midlands, where your expertise as a Qualified Person will be valued in a collaborative and high-impact environment. With a commitment to quality and compliance, the company offers a competitive salary, comprehensive benefits, and ample opportunities for professional growth, making it an excellent employer for those seeking meaningful and rewarding work in the pharmaceutical industry.
StudySmarter Expert Advice🤫
We think this is how you could land Qualified Person in Liverpool
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Thor. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Thor.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Thor. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Thor is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Qualified Person in Liverpool
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Thor!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Thor that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Thor!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Thor, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Thor
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Thor that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Thor’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
