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 in pharmaceutical quality assurance.
- Qualifications: Must be eligible as a Qualified Person with experience in QP certification.
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 in Stoke-on-Trent 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 values innovation and quality, where your contributions directly impact patient safety and product excellence.
StudySmarter Expert Advice🤫
We think this is how you could land Qualified Person (QP) - Sterile Manufacturing in Stoke-on-Trent
✨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 Practices and the specific requirements of the role. We recommend practising common interview questions related to batch certification and quality management to show you’re the right fit.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, drop a quick thank-you email to express your appreciation and reiterate your enthusiasm for the role. It keeps you fresh in their minds!
✨Tip Number 4
Check out our website for the latest job postings and apply directly through us. We make it easy for you to find roles that match your skills and experience, so don’t miss out on your dream job!
We think you need these skills to ace Qualified Person (QP) - Sterile Manufacturing in Stoke-on-Trent
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 sterile manufacturing. Share specific examples of your previous work that demonstrate your attention to detail and ability to improve quality systems.
Showcase Your Team Spirit:Since this role involves working closely with other QPs and site staff, make sure to highlight your teamwork skills. We love candidates who can foster good relationships and promote a quality culture across teams, so share any relevant experiences!
Apply Through Our Website:Don't forget to apply through our website! It’s the best 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 StudySmarter!
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 critical framework within which a Qualified Person operates.
✨Showcase Your Experience
Prepare specific examples from your previous roles where you've successfully handled batch certification, deviations, or audits. This will help demonstrate your hands-on experience and how it aligns with the responsibilities of the role.
✨Emphasise Teamwork
Since the role involves liaising with cross-functional teams, be ready to discuss how you've built relationships and collaborated with others in past positions. Highlight any mentoring or coaching experiences to showcase your leadership skills.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's quality culture and how they handle inspections or continuous improvements. This not only shows your interest but also helps you gauge if the company is the right fit for you.
