QA Systems Specialist

JR United Kingdom; Stevenage; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading company is seeking a QA Systems Specialist to enhance the implementation and validation of electronic Quality Management Systems. This role involves managing documentation, ensuring compliance with regulatory standards, and providing training while working in a culture focused on innovation and integrity.

Qualifications

• Degree preferred in Life Sciences, Engineering, or Computer Science.
• Experience with MasterControl, ETQ, or similar platforms.
• Strong knowledge of GxP, GLP, and CSV standards.

Responsibilities

• Lead and support eQMS implementation and validation activities.
• Maintain and manage system lifecycle documentation.
• Ensure systems remain audit-ready and compliant.

Skills

Communication

Project Coordination

Education

Degree in Life Sciences, Engineering, Computer Science, or related field

Tools

MasterControl

ETQ

Empower CDS

Job description

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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
• 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