At a Glance
- Tasks: Ensure quality oversight and validation for exciting facility expansion projects.
- Company: Join Eisai, a leading pharmaceutical company focused on human healthcare.
- Benefits: Competitive salary, bonus, free parking, and learning opportunities.
- Other info: Dynamic role with excellent career growth in a supportive environment.
- Why this job: Make a real impact in healthcare by ensuring compliance and quality.
- Qualifications: Knowledge of quality control systems and electronic validation processes.
The predicted salary is between 30000 - 40000 € per year.
Eisai is a leading research based pharmaceutical organisation with an extensive portfolio across the Oncology, Neurology and Pain therapy areas. Eisai Manufacturing is the hub of Eisai’s production and supply chain. We make tablets, package these into blisters, label and pack vials and bottles. We also manage the wider medicines supply chain and other companies who undertake work on our behalf. By joining Eisai, you will be working for an organisation with a human healthcare philosophy, which means that we put the patient first in everything we do.
Your new role
This role is responsible for providing Quality oversight, validation expertise and strategic support for the successful delivery of EML’s facility expansion projects. The role ensures that all qualification and validation activities associated with new facilities, utilities, warehouse operations, and packaging lines are planned and executed in accordance with EML procedures, regulatory expectations, and industry standards. The job holder will support the development and implementation of validation strategies for the new UK cold-chain warehouse, new vial packaging line, new auto-injector packaging line, and associated facility and utility upgrades, ensuring compliance with GMP, GDP, Annex 15, GAMP 5, and EMLs procedures. The role will provide Quality review and approval of validation documentation, risk assessments, commissioning and qualification deliverables, and ensure that systems, equipment, and facilities are introduced in a compliant and controlled manner. It will also contribute to the creation, review and maintenance of validation-related policies, procedures and templates to ensure they remain aligned with current regulatory and project requirements. The job holder will act as a Quality Subject Matter Expert (SME) for qualification, validation, and CSV within the scope of the facility expansion projects, ensuring the application of data integrity principles and supporting successful project execution from design through to handover and operational readiness. This is a 1yr salaried fixed term contract.
What are we looking for?
- Ability to establish and maintain effective working relationships and communication links within EML, affiliated organisations and other customers
- Ability to understand and analyse user requirements to facilitate changes and system improvements
- Proficient knowledge of electronic systems, CSV and GAMP requirements
- Working knowledge of facility and utility systems such as HVAC, compressed air, environmental monitoring systems
- Good understanding of the requirements of data integrity and application to system management
- Good understanding of Quality Control Systems and analytical software and electronic Quality Systems
- Good technical and scientific judgement
- Ability to interpret complex data and present key findings
- Ability to describe technical information in easy-to-understand terms
- Computer literate e.g. Word, Excel and PowerPoint
- Good understanding of GMP Guidelines and Regulations
- Knowledge of the qualification and validation requirements for equipment and electronic systems
- Maintain knowledge and understanding of technical advancements in electronic systems
What we offer in return
Eisai offers a competitive salary and excellent wider benefits package that includes:
- Electric charging points for Electric/Hybrid vehicles
- Discretionary Bonus
- Free onsite parking
- Subsidised onsite restaurant and coffee shop
- Learning and development opportunities
- Well-being
Quality Validation Specialist employer: Eisai EMEA
Eisai is an exceptional employer that prioritises a human healthcare philosophy, ensuring that patient needs are at the forefront of our operations. Located in a state-of-the-art facility, we offer a collaborative work culture that fosters professional growth through extensive learning and development opportunities. With a competitive salary, excellent benefits including electric vehicle charging points, and a commitment to employee well-being, Eisai is dedicated to creating a rewarding and meaningful workplace for all staff.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Validation Specialist
✨Tip Number 1
Network like a pro! Reach out to current employees at Eisai on LinkedIn or through industry events. A friendly chat can give you insider info and might just get your foot in the door.
✨Tip Number 2
Prepare for the interview by knowing your stuff! Brush up on GMP guidelines, validation processes, and any recent advancements in electronic systems. Show them you’re not just a candidate, but a passionate expert ready to contribute.
✨Tip Number 3
Practice makes perfect! Do mock interviews with friends or use online platforms. Get comfortable explaining complex data in simple terms, just like you’d need to do in the role.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re serious about joining the Eisai team and contributing to their mission.
We think you need these skills to ace Quality Validation Specialist
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Quality Validation Specialist role. Highlight your relevant experience in validation, quality control systems, and any specific projects that align with our needs at Eisai.
Craft a Compelling Cover Letter:Your cover letter should tell us why you’re passionate about quality oversight and how your skills can contribute to our mission of putting patients first. Be genuine and let your personality shine through!
Showcase Your Technical Skills:We want to see your proficiency in electronic systems and your understanding of GMP guidelines. Include specific examples of how you've applied these skills in past roles to demonstrate your expertise.
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 Eisai.
How to prepare for a job interview at Eisai EMEA
✨Know Your Quality Standards
Familiarise yourself with GMP, GDP, and Annex 15 regulations. Be ready to discuss how these standards apply to the role of a Quality Validation Specialist and share examples of how you've ensured compliance in past projects.
✨Showcase Your Technical Expertise
Prepare to talk about your experience with electronic systems, CSV, and GAMP requirements. Highlight any specific projects where you’ve implemented validation strategies or improved system management, as this will demonstrate your capability as a Subject Matter Expert.
✨Communicate Clearly
Practice explaining complex technical information in simple terms. This is crucial for building effective working relationships within the team and with other stakeholders. Use examples from your experience to illustrate how you’ve successfully communicated technical details in the past.
✨Demonstrate Problem-Solving Skills
Be prepared to discuss how you've analysed user requirements and facilitated changes or improvements in previous roles. Think of specific challenges you've faced and how you approached them, as this will show your ability to contribute to successful project execution.
