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- Tasks: Ensure quality and compliance in batch certification of sterile medicinal products.
- Company: Exciting pharmaceutical company focused on innovation and quality.
- Benefits: Competitive salary, bonus scheme, pension, and 25 days holiday.
- Why this job: Join a dynamic team and make a real impact in the pharmaceutical industry.
- Qualifications: Must be eligible as a Qualified Person with relevant experience in pharmaceuticals.
- Other info: Opportunity for career growth and to promote a quality culture.
The predicted salary is between 50000 - 65000 £ per year.
AssureBio is working in partnership with an exciting pharmaceutical company to recruit a Qualified Person (QP) who will play a key role in batch certification of sterile medicinal products. The information below covers the role requirements, expected candidate experience, and accompanying qualifications.
Main Duties:
- To undertake the duties of Qualified Person
- To review and evaluate batch records and perform batch certification and release in accordance with Good Manufacturing Practice and the Marketing Authorisation / Clinical Trial Authorisation as appropriate.
- Work with the Head of Quality and other QPs in maintaining and improving the Global Quality system
- Review and approval of deviations, complaints, CAPAs, change controls and out of specification investigations
- Review and approval of Standard Operating Procedures and Forms
- Review and approval of qualification / validation protocols and reports
- Perform internal and supplier audits
- To act as coach and mentor to the site team in aspects of Quality and Continual Improvements.
- Training of site staff in QMS requirements
- Develop and maintain good working relationships with all site staff, QPs and the Inspectorate
- Attend site Quality Management Meetings and be proactive in addressing any issues identified
- Actively participate in MHRA inspections of the main site and other sites as required
- Perform line management responsibilities for subordinates as required, including management of workload and tasks required
- Promoting a quality culture across the site by liaising with cross functional teams
Qualifications/Experience:
- Eligible to be nominated as a Qualified Person EU Directive 2001/83/EC as amended (Medicinal Products for Human Use)
- Previous experience in QP certification of medicinal products
- Previous experience in a pharmaceutical manufacturing organisation, ideally with sterile products
- Experience of line and performance management (QA/QC)
- High levels of attention to detail, with the ability to work efficiently in a fast paced environment
What’s on offer:
- Competitive salary
- Bonus scheme
- Pension Scheme
- 25 days holiday
- Additional benefits
Qualified Person (QP) in Lichfield employer: AssureBio
Contact Detail:
AssureBio Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Qualified Person (QP) in Lichfield
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those who work in quality assurance. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on Good Manufacturing Practices and relevant regulations. We want you to be ready to discuss how your experience aligns with the role of a Qualified Person, so practice articulating your past achievements.
✨Tip Number 3
Showcase your passion for quality! During interviews, share examples of how you've promoted a quality culture in previous roles. This will demonstrate your commitment and fit for the position.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take that extra step to connect with us directly.
We think you need these skills to ace Qualified Person (QP) in Lichfield
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Qualified Person role. Highlight your experience in batch certification and any relevant qualifications that align with the job description. We want to see how your background fits perfectly with what we're looking for!
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 skills can contribute to our team. Keep it engaging and relevant to the role.
Showcase Your Attention to Detail: Since this role requires high levels of attention to detail, make sure your application is free from typos and errors. We appreciate candidates who take the time to present their best work right from the start!
Apply Through Our Website: We encourage you to apply through our website for a smoother 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 AssureBio
✨Know Your Regulations
Familiarise yourself with the EU Directive 2001/83/EC and Good Manufacturing Practice (GMP) guidelines. Being able to discuss these regulations confidently will show that you understand the critical framework within which a Qualified Person operates.
✨Showcase Your Experience
Prepare specific examples from your previous roles where you successfully handled batch certification, deviations, or audits. Highlighting your hands-on experience in a pharmaceutical manufacturing environment, especially with sterile products, will make you stand out.
✨Emphasise Teamwork and Leadership
Since the role involves coaching and mentoring, be ready to discuss how you've previously led teams or improved quality systems. Share instances where you fostered collaboration across departments to promote a quality culture.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's quality management practices and how they handle inspections. This not only shows your interest but also demonstrates your proactive approach to understanding their operations.