QA Systems Specialist

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

Job summary

Une entreprise dynamique recherche un QA Systems Specialist pour rejoindre son équipe. Le candidat idéal dirigera l'implémentation et la validation de systèmes de gestion de la qualité, tout en garantissant la conformité avec les normes réglementaires. Une excellente communication et des compétences en coordination de projet sont essentielles pour réussir à ce poste.

Qualifications

• Expérience en validation de systèmes QMS et techniques de documentation.
• Solide connaissance des normes réglementaires GxP, GLP et CSV.
• Capacité à travailler avec des technologies avancées.

Responsibilities

• Diriger la mise en œuvre et la validation des systèmes de gestion de la qualité.
• Former et soutenir les utilisateurs des systèmes.
• Assurer que les systèmes restent conformes aux exigences réglementaires.

Skills

Validation documentation

Project coordination

Communication

System configuration

Knowledge of regulatory standards

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