At a Glance
- Tasks: Join our QA team to ensure compliance through validation procedures and data analysis.
- Company: Sekisui Diagnostics innovates diagnostic tests to enhance patient outcomes globally.
- Benefits: Enjoy competitive pay, diverse workplace culture, and opportunities for growth.
- Other info: This is a full-time temporary role starting summer 2025.
- Why this job: Make a real impact in healthcare while gaining valuable experience in quality assurance.
- Qualifications: Knowledge of EudraLex guidelines and ISO quality systems is essential.
The predicted salary is between 36000 - 60000 £ per year.
Temporary Associate Validation Specialist
We are seeking a Temporary Associate Validation Specialist to join our QA department on a full-time basis for up to one year starting summer 2025.
The role involves preparing complex validation procedures and protocols to ensure manufacturing compliance with regulatory requirements, internal standards, and industry practices. Responsibilities include analyzing validation data, preparing reports, troubleshooting issues, and maintaining validation documentation.
Key responsibilities include:
- Performing validation activities for facilities, equipment, and processes in accordance with EudraLex Volume 4 – GMP guidelines and other quality system requirements.
- Reviewing and updating validation procedures such as policies, master plans, and SOPs.
- Establishing and maintaining validation plans and schedules for requalification and temperature mapping.
- Collaborating with Engineering, Quality Assurance, and User Departments to ensure timely validation activities with minimal disruption.
The ideal candidate will have education and/or experience in areas including:
- Knowledge of EudraLex Volume 4, including Annex 11 and 15 validation requirements.
- Understanding of ISO 9001 and ISO 13485 quality systems.
- Familiarity with IQ, QQ, PQ, PV validation types.
- Experience with temperature mapping and calibration principles.
- Ability to author and execute validation reports and procedures.
If you are interested, please apply now for immediate consideration.
About Sekisui Diagnostics:
We focus on innovating highly accurate diagnostic tests, reagents, and systems to improve patient outcomes. With state-of-the-art manufacturing and a global sales network, we serve healthcare professionals worldwide. We offer competitive compensation, benefits, and a commitment to diversity and equal opportunity.
#J-18808-LjbffrTemporary Associate Validation Specialist employer: Sekisui Diagnostics GmbH
At Sekisui Diagnostics, we pride ourselves on being an excellent employer, offering a dynamic work culture that fosters innovation and collaboration. Our commitment to employee growth is evident through comprehensive training programmes and opportunities for advancement within the healthcare sector. Located in a state-of-the-art facility, we provide competitive compensation and benefits, ensuring our team members feel valued and supported in their mission to improve patient outcomes.
StudySmarter Expert Advice🤫
We think this is how you could land Temporary Associate Validation Specialist
✨Get Familiar with Temporary Roles in Pharma
Temporary positions in the pharmaceutical industry often arise during specific periods, like product launches or seasonal hiring sprints. Keep an eye on timelines and be proactive in reaching out to companies, especially around these busy times!
✨Join Pharma Networking Events
Participate in local and virtual pharmaceutical networking events or job fairs. This is a fantastic way to get in front of hiring managers and learn more about temporary opportunities directly from those in the know.
✨Leverage Your University Career Services
If you’re a student or recent grad, tap into your university’s career services which often have specific connections to pharma companies looking to fill temporary roles. They might even have exclusive internship programmes that lead to temp jobs!
✨Be Visible Online and Offline
Utilise platforms like LinkedIn to share your interests in temporary roles and connect with industry professionals. Plus, consider writing about relevant pharmaceutical topics to showcase your knowledge and enthusiasm—this can help you stand out to hiring companies like Sekisui Diagnostics GmbH.
We think you need these skills to ace Temporary Associate Validation Specialist
Some tips for your application 🫡
Highlight Your Relevant Experience:In the pharmaceutical industry, it's crucial to showcase any relevant experience you have, whether it's internships, lab work, or coursework. Let’s emphasise your familiarity with drug development processes and any hands-on experience you've had with lab equipment or clinical trials in your CV.
Mention Certifications and Training:If you’ve got any certifications relevant to pharmaceuticals, like Good Clinical Practice (GCP) or a certification in pharmacovigilance, make sure to include them. These show your commitment to the field and can make a positive impact on your application for a temporary role at Sekisui Diagnostics GmbH.
Show Your Flexibility and Availability:Temporary positions often require immediate availability and flexibility in working hours. In your cover letter, make it clear when you can start and your ability to adapt to changing schedules, as this is key to a successful application.
Express Your Learning Goals:Since this is a temporary role, we suggest discussing what you hope to learn or gain from the experience at Sekisui Diagnostics GmbH. This not only shows your eagerness but also helps employers see you as someone who’s ready to make the most out of the opportunity.
How to prepare for a job interview at Sekisui Diagnostics GmbH
✨Know Your Regulations
In the pharmaceutical industry, it’s crucial to understand key regulations like GMP (Good Manufacturing Practices) or GCP (Good Clinical Practices). Brush up on these standards and be ready to discuss how they influence your work approach during your interview with Sekisui Diagnostics GmbH.
✨Emphasise Adaptability
Since this is a temporary role, show that you're ready to hit the ground running. Share examples from your past experiences that demonstrate your ability to adapt quickly to new environments or changes, especially in a fast-paced setting like pharmaceuticals.
✨Highlight Relevant Skills and Tools
Whether it’s laboratory techniques or software like LabWare or SAS, make sure you can confidently talk about your technical skills. If you have experience with any specific tools used in previous roles, relate that directly to how it can help Sekisui Diagnostics GmbH achieve its goals.
✨Prepare for Technical Questions
Be ready for technical questions related to drug development processes or quality assurance. We should expect scenarios where you might have to troubleshoot a problem or suggest improvements on a project—this shows your problem-solving capability in a temporary role.
