QA Systems Specialist

JR United Kingdom; Chelmsford; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading company seeks a QA Systems Specialist to support the implementation and maintenance of electronic Quality Management Systems. The position involves managing system documentation, ensuring compliance, and providing user support. Ideal candidates will have a relevant degree and experience with QMS platforms, enhancing drug development initiatives.

Qualifications

• Experience with MasterControl, ETQ, or similar QMS platforms preferred.
• Strong knowledge of CSV and pharmaceutical regulatory standards required.
• Skilled in validation documentation and system configuration.

Responsibilities

• Lead and support eQMS implementation, migration, and validation activities.
• Ensure systems remain audit-ready and compliant with GxP, GLP, and CSV requirements.
• Provide training and ongoing support to system users and stakeholders.

Skills

Communication

Project Coordination

Validation Documentation

System Configuration

Education

Degree in Life Sciences

Degree in Engineering

Degree in Computer Science

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