At a Glance
- Tasks: Ensure quality systems meet compliance and improve GMP-related processes.
- Company: Join CSL Seqirus, a leading global influenza vaccine provider.
- Benefits: Enjoy competitive benefits and a culture of inclusion and belonging.
- Other info: Dynamic work environment with opportunities for continuous improvement and career growth.
- Why this job: Make a real impact in healthcare by ensuring quality in vaccine production.
- Qualifications: Bachelor's degree in a relevant field and 5+ years in quality systems.
The predicted salary is between 40500 - 49500 £ per year.
Responsibilities:
- Under general direction, provides support on Quality systems to ensure compliance with company standards and GMP regulatory guidelines.
- Develops, maintains and improves GMP-related quality control systems including standard operating procedures (SOPs).
- Participates in project teams to provide review and approval of project validation documentation according to applicable approval matrix or procedures.
- Supports quality systems related to Validation, LIMS, Calibration, Document Management, Deviation Management, CAPA, Change Control, and Enterprise Learning Management.
- Writes and manages validation plans, ensuring appropriate, timely validation/revalidation is maintained.
- Conducts internal audits and assists with 3rd party quality audit; plans and implements continuous improvement projects.
- Supports GxP health authority inspections by serving as subject matter expert for computerized systems topics.
- Provides guidance on quality and regulatory requirements to project teams, internal stakeholders and other teams on GxP compliance relating to computerized systems.
- Collaborates to resolve technical issues, provide quality training and communicate best practices.
Qualifications:
- Bachelor degree in Engineering or a relevant scientific discipline (Chemistry, Biology, Microbiology, IT etc.) or equivalent experience.
- 5+ years’ quality systems experience in pharmaceutical manufacturing/cGMP regulated environment.
- Knowledge of current Good Manufacturing Practices (cGMP).
- Knowledge of FDA and EMA requirements.
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
Digital Quality Manager in Maidenhead employer: CSL
CSL Seqirus is an excellent employer that fosters a collaborative and inclusive work culture, making it an ideal place for a Global Financial Analyst. With a strong focus on employee growth and development, the company offers numerous opportunities for professional advancement while providing a hybrid working model that promotes work-life balance. Located in Speke, Liverpool, employees benefit from a vibrant community and the chance to engage with diverse teams across the globe, enhancing both personal and professional experiences.
StudySmarter Expert Advice🤫
We think this is how you could land Digital Quality Manager in Maidenhead
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like CSL. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like CSL.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like CSL. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what CSL is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Digital Quality Manager in Maidenhead
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at CSL!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show CSL that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at CSL!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At CSL, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at CSL
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at CSL that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with CSL’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
