QA Systems Specialist

JR United Kingdom; Coventry; On-site; GBP 35,000 - 50,000; Full time

Job summary

A leading company is seeking a QA Systems Specialist to enhance and support electronic Quality Management Systems. This role involves leading implementation and validation activities, maintaining critical documentation, and ensuring compliance with pharmaceutical standards. Ideal candidates will possess a relevant degree and strong experience with quality systems like MasterControl or ETQ, contributing to drug development initiatives.

Qualifications

• Experience with MasterControl or ETQ QMS platforms.
• Strong knowledge of CSV and pharmaceutical standards.
• Skilled in validation documentation.

Responsibilities

• Lead eQMS implementation and validation activities.
• Manage system lifecycle documentation (URS, IQ/OQ/PQ).
• Ensure systems remain compliant with regulatory standards.

Skills

Communication

Project Coordination

Validation Documentation

System Configuration

Education

Degree in Life Sciences, Engineering, or Computer Science

Tools

MasterControl

ETQ

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