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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, a culture of innovation, and collaboration opportunities.
- 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 scientific challenges.
The predicted salary is between 36000 - 60000 £ per year.
Are you an QA Systems Specialist seeking their next exciting opportunity? 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
Benefits
- 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
Contact Detail:
LinkedIn Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QA Systems Specialist
✨Tip Number 1
Familiarise yourself with the specific eQMS platforms mentioned in the job description, like MasterControl and ETQ. Having hands-on experience or even a basic understanding of these systems can set you apart during discussions.
✨Tip Number 2
Brush up on your knowledge of GxP, GLP, and CSV requirements. Being able to speak confidently about these regulations will demonstrate your expertise and commitment to compliance, which is crucial for this role.
✨Tip Number 3
Prepare to discuss your experience with validation documentation and system configuration. Be ready to share specific examples of how you've contributed to similar projects in the past, as this will showcase your practical skills.
✨Tip Number 4
Network with professionals in the pharmaceutical industry, especially those who work with quality management systems. Engaging with others in the field can provide valuable insights and potentially lead to referrals for the position.
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 and any specific platforms like MasterControl or ETQ. Use keywords from the job description to demonstrate your fit for the role.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for quality assurance and your understanding of GxP, GLP, and CSV requirements. Mention specific examples of your past experiences that align with the responsibilities listed in the job description.
Highlight Relevant Skills: In your application, emphasise your skills in validation documentation, system configuration, and project coordination. These are crucial for the QA Systems Specialist role and should be clearly articulated.
Proofread Your Application: Before submitting, carefully proofread your application for any spelling or grammatical errors. A polished application reflects your attention to detail, which is essential in quality assurance roles.
How to prepare for a job interview at LinkedIn
✨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 project coordination skills and how you manage communication with stakeholders. Clear communication is key in QA roles, so be ready to provide examples of how you've successfully managed this in the past.
