QA Systems Specialist

JR United Kingdom; Hemel Hempstead; On-site; GBP 40,000 - 65,000; Full time

Job summary

A leading company in the pharmaceutical sector is looking for a QA Systems Specialist to oversee the implementation and maintenance of critical Quality Management Systems. This role involves managing compliance and ensuring that systems remain audit-ready while providing support and training to users within a collaborative environment. Ideal candidates will have a relevant degree, strong knowledge of regulatory standards, and experience with QMS platforms.

Qualifications

• Degree in Life Sciences or related field preferred.
• Experience with QMS platforms such as MasterControl or ETQ.
• Strong knowledge of GxP and pharmaceutical regulations.

Responsibilities

• Lead and support eQMS implementation and validation activities.
• Maintain system lifecycle documentation and ensure compliance.
• Provide training and support for system users.

Skills

Communication

Project Coordination

Knowledge of CSV

Validation Documentation

System Configuration

Education

Degree in Life Sciences, Engineering or 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