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 mentoring within a collaborative environment.
- Why this job: Join a dynamic team and make a real impact in healthcare.
- Qualifications: Eligible QP with experience in pharmaceutical manufacturing and attention to detail.
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. Please read the following job description thoroughly to ensure you are the right fit for this role before applying.
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 in Lichfield 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, our culture promotes continuous learning and collaboration, supported by competitive salaries, a bonus scheme, and generous holiday allowances. Join us in a location that fosters innovation and excellence, making a meaningful impact in the healthcare sector.
StudySmarter Expert Advice🤫
We think this is how you could land Qualified Person (QP) - Sterile Manufacturing 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 or sterile manufacturing. A friendly chat can lead to insider info about job openings and even referrals.
✨Tip Number 2
Prepare for interviews by brushing up on Good Manufacturing Practices and the specific regulations related to medicinal products. We recommend practising common interview questions and scenarios that relate to batch certification and quality management.
✨Tip Number 3
Showcase your experience! When you get the chance to speak with potential employers, highlight your previous roles in QP certification and how you've contributed to maintaining quality systems. Real-life examples will make you stand out.
✨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 are proactive and engaged in their job search.
We think you need these skills to ace Qualified Person (QP) - Sterile Manufacturing in Lichfield
Some tips for your application 🫡
Read the Job Description Carefully:Before you start your application, make sure to read the job description thoroughly. We want to see that you understand the role of a Qualified Person and how your experience aligns with the responsibilities outlined.
Tailor Your CV and Cover Letter:Don’t just send a generic CV! We love it when applicants tailor their documents to highlight relevant experience in batch certification and quality management. Show us how your background fits the bill!
Showcase Your Attention to Detail:As a QP, attention to detail is crucial. In your application, give examples of how you've demonstrated this skill in previous roles, especially in fast-paced environments. We want to see that you can handle the pressure!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. 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.
