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- Tasks: Lead eQMS implementation and ensure systems are audit-ready.
- Company: Join a dynamic team focused on global drug development.
- Benefits: Enjoy mentorship, collaboration, and a culture of innovation.
- Why this job: Make a real impact in pharmaceutical advancements while growing your skills.
- Qualifications: Degree in Life Sciences or related field; experience with QMS platforms required.
- Other info: Work with cutting-edge technologies and contribute to meaningful projects.
The predicted salary is between 36000 - 60000 £ per year.
We’re helping our client seek an experienced QA Systems Specialist to support the implementation, validation, and maintenance of electronic Quality Management Systems and pharmaceutical computerised systems.
Responsibilities
- Lead and support eQMS implementation, migration, and validation activities
- Maintain and manage system lifecycle documentation (URS, IQ/OQ/PQ, SOPs, etc.)
- Provide training and ongoing support to system users and stakeholders
- Ensure systems remain audit-ready and compliant with GxP, GLP, and CSV requirements
- Act as SME for validated systems and support continuous improvement
- Manage archiving processes and act as GLP archivist
- Communicate project progress and risks
Requirements
- Degree in Life Sciences, Engineering, Computer Science, or related field preferred
- Experience with MasterControl, ETQ, or similar QMS platforms
- Strong knowledge of CSV and pharmaceutical regulatory standards
- Experience with Empower CDS validation and data integrity
- Skilled in validation documentation and system configuration
- Excellent communication and project coordination skills
Contribute to impactful, global drug development initiatives. Benefit from mentorship and guidance from experienced industry leaders. Thrive in a culture rooted in integrity, innovation, and lifelong learning. Collaborate across functions to tackle real-world scientific challenges. Work with advanced technologies and proprietary research platforms.
QA Systems Specialist employer: JR United Kingdom
Contact Detail:
JR United Kingdom Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QA Systems Specialist
✨Tip Number 1
Familiarise yourself with the specific Quality Management Systems (QMS) mentioned in the job description, such as MasterControl and ETQ. Having hands-on experience or even a solid understanding of these platforms can set you apart from other candidates.
✨Tip Number 2
Brush up on your knowledge of CSV (Computer System Validation) and pharmaceutical regulatory standards. Being able to discuss these topics confidently during an interview will demonstrate your expertise and commitment to compliance.
✨Tip Number 3
Prepare to showcase your project coordination skills by thinking of examples where you've successfully managed projects or led teams. Highlighting your ability to communicate effectively and manage risks will resonate well with the hiring team.
✨Tip Number 4
Network with professionals in the pharmaceutical industry, especially those who work with eQMS. Engaging with them can provide insights into the role and may even lead to referrals, increasing your chances of landing the job.
We think you need these skills to ace QA Systems Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in Quality Management Systems, particularly with platforms like MasterControl or ETQ. Emphasise your knowledge of CSV and pharmaceutical regulatory standards.
Craft a Compelling Cover Letter: In your cover letter, express your enthusiasm for the role and how your background aligns with the responsibilities listed. Mention specific projects where you've led eQMS implementation or validation activities.
Highlight Relevant Skills: Clearly outline your skills in validation documentation, system configuration, and project coordination. Use examples to demonstrate your communication abilities and how you've supported system users in the past.
Showcase Continuous Improvement: Discuss any initiatives you've taken to improve processes or systems in previous roles. This could include training sessions you've conducted or improvements made to ensure compliance with GxP, GLP, and CSV requirements.
How to prepare for a job interview at JR United Kingdom
✨Know Your QMS Platforms
Familiarise yourself with MasterControl, ETQ, or any similar QMS platforms. Be prepared to discuss your experience with these systems and how you've used them in past roles.
✨Understand Regulatory Standards
Brush up on your knowledge of CSV and pharmaceutical regulatory standards. Being able to articulate how you ensure compliance will demonstrate your expertise and readiness for the role.
✨Showcase Your Documentation Skills
Prepare examples of validation documentation you've worked on, such as URS, IQ/OQ/PQ, and SOPs. Highlighting your attention to detail in these areas can set you apart from other candidates.
✨Communicate Effectively
Practice articulating your thoughts clearly and concisely. Strong communication skills are essential for this role, especially when discussing project progress and risks with stakeholders.
