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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: Experience in QP certification and pharmaceutical manufacturing required.
- 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.
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) employer: AssureBio
Contact Detail:
AssureBio Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Qualified Person (QP)
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those who are already working as Qualified Persons. They can provide insider info and might even refer you to open positions.
✨Tip Number 2
Prepare for interviews by brushing up on Good Manufacturing Practice (GMP) and relevant regulations. We recommend practising common interview questions related to batch certification and quality management to show you're the right fit.
✨Tip Number 3
Showcase your experience with real-life examples during interviews. Talk about specific situations where you’ve successfully handled deviations or audits, as this will demonstrate your expertise and problem-solving skills.
✨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 the initiative to engage directly with us.
We think you need these skills to ace Qualified Person (QP)
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 previous experiences make you the ideal candidate. We love seeing enthusiasm and a personal touch!
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, so double-check everything before hitting send!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the easiest 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 AssureBio!
How to prepare for a job interview at AssureBio
✨Know Your Regulations
Familiarise yourself with the EU Directive 2001/83/EC and other relevant regulations. Being able to discuss these in detail will show your understanding of the role and its responsibilities.
✨Showcase Your Experience
Prepare specific examples from your previous roles where you successfully handled batch certification or quality management. Highlight any experience with sterile products, as this is crucial for the position.
✨Demonstrate Attention to Detail
During the interview, be ready to discuss how you ensure accuracy in your work. You might want to share methods you use to maintain high standards in quality assurance and how you handle deviations or complaints.
✨Build Rapport with the Interviewers
Since the role involves working closely with various teams, practice building a connection with your interviewers. Show enthusiasm for collaboration and your ability to mentor others in quality practices.