At a Glance
- Tasks: Lead quality analysis and support IT systems for life-changing pharmaceutical treatments.
- Company: Join a pioneering pharmaceutical company driving digital transformation.
- Benefits: Competitive salary, career growth, and the chance to make a real impact.
- Other info: Collaborative culture with opportunities to work on smart factory initiatives.
- Why this job: Be at the forefront of innovation and improve healthcare outcomes.
- Qualifications: Background in computer science or equivalent experience in regulated environments.
The predicted salary is between 40000 - 50000 £ per year.
Ready to lead quality analysis that helps bring life-changing treatments to the world? Join our client at the forefront of pharmaceutical innovation and make a difference!
Proclinical is recruiting for a dedicated Quality Analyst to support the digital transformation journey of a manufacturing site, focusing on implementing and maintaining IT systems that align with GMP regulations.
This role will primarily involve working with Quality Systems such as LIMS, CDS, and other QC equipment applications, while also supporting broader manufacturing IT needs.
You will collaborate with cross‑functional teams, including business stakeholders, IT colleagues, and external vendors, to deliver effective solutions and ensure ongoing system compliance and optimization.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Responsibilities
- Implement and maintain IT systems and processes in line with GMP regulations, focusing on Quality Systems (e. g., LIMS, CDS, QC equipment applications).
- Provide day‑to‑day IT support, including issue resolution, system changes, and service optimization.
- Manage IT requests via the ticketing system and ensure timely responses.
- Facilitate deviation and CAPA management, ensuring regulatory compliance and continuous improvement.
- Author and update validation documentation, IT data processes, and other compliance‑related materials.
- Support audits and inspections related to IT quality and regulatory compliance.
- Collect business requirements and translate them into solution specifications.
- Participate in application design discussions and ensure adherence to established standards.
- Lead or support validation activities for IT systems and software applications.
- Conduct testing and implementation of new applications, ensuring cybersecurity compliance.
- Identify opportunities for process improvements and implement strategic changes to enhance operational efficiency.
- Stay updated on industry trends, regulatory changes, and best practices related to Quality Systems and Smart Labs.
- Contribute to smart factory initiatives and collaborate with other teams as needed.
- Key Skills and Requirements
- Background in computer science, information systems, or equivalent experience in a regulated environment.
- Experience supporting pharmaceutical quality and manufacturing systems.
- Knowledge of system lifecycle management and computer systems validation (CSV), preferably GAMP5.
- Hands‑on experience with LIMS, CDS, and Quality Systems.
- Familiarity with ITILv4 and project management principles.
- Proficiency in SQL, data management, and analytics is advantageous.
- Strong problem‑solving skills and attention to detail.
- Excellent communication skills, with the ability to explain technical concepts to non‑technical colleagues.
- Collaborative mindset and willingness to work closely with Quality and other business teams.
- Self‑starter with the ability to manage multiple projects simultaneously.
- #J-18808-Ljbffr
Quality Information System Analyst in Hatfield employer: Proclinical Group
Proclinical Group is an excellent employer, offering a dynamic work culture that fosters collaboration and innovation in the field of diagnostic technologies. Employees benefit from comprehensive training programs, opportunities for professional growth, and the chance to make a meaningful impact on customer satisfaction and business success in the vibrant location of Croydon, UK.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Information System Analyst in Hatfield
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Proclinical Group. 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 Proclinical Group.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Proclinical Group. 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 Proclinical Group is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Quality Information System Analyst in Hatfield
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 Proclinical Group!
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 Proclinical Group 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 Proclinical Group!
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 Proclinical Group, 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 Proclinical Group
✨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 Proclinical Group 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 Proclinical Group’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.
