QA Systems Specialist

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

Job summary

A leading company is seeking a QA Systems Specialist in Bolton. The role involves leading the implementation and validation of electronic Quality Management Systems, ensuring compliance with GxP, GLP, and CSV standards. This position offers a strong opportunity to contribute to impactful drug development initiatives.

Qualifications

• Experienced in eQMS implementation, validation, and maintenance.
• Excellent communication and coordination skills are crucial.

Responsibilities

• Lead implementation and validation of QA systems.
• Ensure audit readiness and compliance with regulatory standards.

Skills

Communication

Project Coordination

Regulatory Standards Knowledge

Education

Degree in Life Sciences, Engineering, or Computer Science

Tools

MasterControl

ETQ

Job description

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QA Systems Specialist, bolton, greater manchester

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Client:

Blackfield Associates

Location:

bolton, greater manchester, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Views:

3

Posted:

07.06.2025

Expiry Date:

22.07.2025

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Job Description:

QA Systems Specialist

Location: South East

Job Type: Permanent

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