QA Systems Specialist

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

Job summary

A leading company is seeking a QA Systems Specialist to oversee the implementation and validation of electronic Quality Management Systems in the pharmaceutical sector. This role involves leading validation activities, ensuring compliance with regulatory standards, and collaborating across functions to support drug development initiatives. Candidates with a background in life sciences or engineering, alongside experience in QMS platforms, will thrive in a culture focused on integrity and innovation.

Qualifications

• Degree preferred in Life Sciences, Engineering, or Computer Science.
• Experience with QMS platforms like MasterControl and ETQ.
• Strong knowledge of CSV and pharmaceutical standards required.

Responsibilities

• Lead and support eQMS implementation and validation activities.
• Maintain system lifecycle documentation and ensure audit readiness.
• Provide training and support to users and manage archiving processes.

Skills

Communication

Project Coordination

Validation Documentation

System Configuration

Knowledge of CSV

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