QA Systems Specialist

JR United Kingdom; Reading; On-site; GBP 35,000 - 48,000; Full time

Job summary

JR United Kingdom recherche un spécialiste QA pour un rôle clé dans l'implémentation et la validation de systèmes qualité. Le candidat devra gérer la documentation, fournir une formation, et s'assurer que les systèmes sont conformes aux normes réglementaires. Une expertise en MasterControl et une solide connaissance des normes CSV sont essentielles.

Qualifications

• Expérience avec des plateformes QMS telles que MasterControl ou ETQ.
• Connaissance approfondie des normes réglementaires pharmaceutiques.
• Capacité à rédiger une documentation de validation.

Responsibilities

• Diriger et soutenir l'implémentation et la validation des systèmes QMS.
• Maintenir la documentation du cycle de vie du système.
• Assurer que les systèmes restent conformes aux exigences GxP.

Skills

CSV

Compétences en communication

Coordination de projet

Intégrité des données

Education

Diplôme en sciences de la vie, ingénierie, informatique ou domaine connexe

Tools

MasterControl

ETQ

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