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- Tasks: Lead eQMS implementation and ensure systems are compliant and audit-ready.
- Company: Join a dynamic team focused on global drug development and innovation.
- Benefits: Enjoy mentorship, collaboration, and a culture of integrity and lifelong learning.
- Why this job: Make a real impact in pharmaceutical advancements while working with cutting-edge technologies.
- Qualifications: Degree in Life Sciences or related field; experience with QMS platforms required.
- Other info: This is a permanent role located in the South East.
The predicted salary is between 36000 - 60000 £ per year.
Location: South East
Job Type: Permanent
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
QA Systems Specialist employer: Blackfield Associates
Contact Detail:
Blackfield Associates 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 completing online tutorials can give you a significant edge during interviews.
✨Tip Number 2
Brush up on your knowledge of GxP, GLP, and CSV requirements. Being able to discuss these standards confidently will demonstrate your expertise and commitment to compliance, which is crucial for this role.
✨Tip Number 3
Prepare examples from your past experiences where you've successfully led eQMS implementation or validation projects. Highlighting your project management skills and ability to communicate progress will resonate well with potential employers.
✨Tip Number 4
Network with professionals in the pharmaceutical industry, especially those who work with quality management systems. Engaging in relevant forums or LinkedIn groups can provide 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, 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 experiences that demonstrate your skills in eQMS implementation and validation.
Highlight Relevant Skills: Clearly outline your skills in validation documentation, system configuration, and project coordination. Use examples to illustrate how you've successfully managed similar tasks in previous roles.
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 crucial for a QA Systems Specialist.
How to prepare for a job interview at Blackfield Associates
✨Know Your Systems
Familiarise yourself with electronic Quality Management Systems (eQMS) and specific platforms like MasterControl or ETQ. Be prepared to discuss your experience with these systems and how you've contributed to their implementation and validation in previous roles.
✨Understand Regulatory Standards
Brush up on GxP, GLP, and CSV requirements. Demonstrating a solid understanding of these standards will show that you are well-prepared to ensure compliance and maintain audit readiness in the role.
✨Showcase Your Communication Skills
As a QA Systems Specialist, you'll need to communicate effectively with various stakeholders. Prepare examples of how you've successfully communicated project progress, risks, and provided training to users in past positions.
✨Highlight Continuous Improvement Initiatives
Be ready to discuss any initiatives you've led or participated in that focused on continuous improvement within QA processes. This could include system enhancements, process optimisations, or training programmes that improved user engagement.
