At a Glance
- Tasks: Ensure quality and compliance in the certification of sterile medicinal products.
- Company: Exciting pharmaceutical company focused on innovation and quality.
- Benefits: Competitive salary, bonus scheme, pension, and 25 days holiday.
- Other info: Opportunity for career growth and to promote a quality culture.
- Why this job: Join a dynamic team and make a real impact on patient safety.
- Qualifications: Must be eligible as a Qualified Person with relevant experience.
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) - Sterile Manufacturing employer: AssureBio
AssureBio is an exceptional employer, offering a dynamic work environment where the role of Qualified Person (QP) in Sterile Manufacturing is pivotal to ensuring the highest standards of quality in pharmaceutical products. With a strong emphasis on employee growth, you will have opportunities for professional development through mentoring and training, while enjoying a competitive salary, bonus scheme, and generous holiday allowance. Located in a vibrant area, our collaborative culture fosters innovation and teamwork, making it a rewarding place to advance your career in the pharmaceutical industry.
StudySmarter Expert Advice🤫
We think this is how you could land Qualified Person (QP) - Sterile Manufacturing
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those who have experience with QP roles. 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 Practice (GMP) and relevant regulations. We recommend creating a cheat sheet of key points to discuss, so you can confidently showcase your expertise during the interview.
✨Tip Number 3
Don’t just wait for job alerts! Actively search for opportunities on our website and apply directly. This shows initiative and can set you apart from other candidates who are just waiting for the right role to pop up.
✨Tip Number 4
Follow up after interviews! A quick thank-you email reiterating your interest in the role can leave a lasting impression. Plus, it’s a great way to remind them of your enthusiasm for the position.
We think you need these skills to ace Qualified Person (QP) - Sterile Manufacturing
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 the role and how your previous experiences make you the ideal candidate. Don’t forget to mention your familiarity with Good Manufacturing Practice and quality systems.
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 work neatly and accurately, reflecting the quality we uphold at StudySmarter.
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 to do!
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. Being able to discuss these regulations confidently will show that you understand the framework within which you'll be working.
✨Showcase Your Experience
Prepare specific examples from your previous roles where you've successfully handled batch certification or quality management. Highlight any experience with sterile products, as this is crucial for the role.
✨Demonstrate Leadership Skills
Since the role involves coaching and mentoring, think of instances where you've led a team or improved processes. Be ready to discuss how you can promote a quality culture and manage workloads effectively.
✨Engage with Questions
Prepare thoughtful questions about the company's quality systems and their approach to continuous improvement. This shows your genuine interest in the role and helps you assess if it's the right fit for you.
