QA Systems Specialist

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

Job summary

Une entreprise leader dans le secteur pharmaceutique recherche un QA Systems Specialist pour rejoindre son équipe à Milton Keynes. Le candidat idéal dirigera l'implémentation et la validation des systèmes de gestion de la qualité électronique, garantissant leur conformité avec les normes réglementaires. Ce rôle est crucial pour maintenir une culture de l'intégrité et de l'innovation, tout en contribuant au développement de médicaments à l'échelle mondiale.

Qualifications

• Expérience avec des plateformes QMS comme MasterControl ou ETQ souhaitée.
• Connaissance solide des standards réglementaires pharmaceutiques et de la validation CSV.
• Compétences exceptionnelles en communication et en coordination de projet.

Responsibilities

• Diriger et soutenir l'implémentation de systèmes eQMS.
• Assurer que les systèmes restent conformes aux exigences GxP, GLP et CSV.
• Former et soutenir les utilisateurs des systèmes.

Skills

Communication

Coordination de projet

Conformité réglementaire

Validation

Intégrité des données

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