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QA Systems Specialist

JR United Kingdom

Telford

On-site

GBP 40,000 - 60,000

Full time

Yesterday
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Job summary

A leading company in the pharmaceutical sector is seeking a QA Systems Specialist to drive the implementation and management of electronic Quality Management Systems. In this role, you'll ensure compliance with regulatory standards and provide essential support to users and stakeholders, contributing to impactful drug development initiatives while thriving in a culture of innovation and integrity.

Qualifications

  • Experience with QMS platforms required, like MasterControl or ETQ.
  • Strong understanding of pharmaceutical regulatory standards and CSV.
  • Excellent communication and project management skills needed.

Responsibilities

  • Lead eQMS implementation and validation activities.
  • Maintain system lifecycle documentation including URS and SOPs.
  • Ensure compliance with GxP, GLP, and CSV requirements.

Skills

Communication
Project Coordination
Knowledge of CSV
Validation Documentation

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
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