(CSV) Quality Assurance Systems Specialist

MedPharm; Greater London; On-site; GBP 45,000 - 70,000; Full time

Job summary

An established industry player is seeking a QA Systems Specialist to lead the implementation and management of electronic Quality Management Systems. In this pivotal role, you will act as a Subject Matter Expert, ensuring compliance with regulatory standards while driving system migrations and improvements. Your expertise in platforms like ETQ and MasterControl will be crucial as you support the organization in maintaining high-quality pharmaceutical data management. This is an exciting opportunity to influence change and enhance quality assurance processes in a dynamic environment.

Qualifications

• Experience with eQMS platforms and CSV in regulated environments.
• Strong project management skills and ability to influence change.

Responsibilities

• Lead implementation and management of eQMS and CSV projects.
• Ensure compliance with GAMP 5 and industry standards.

Skills

ETQ

MasterControl

Computer System Validation (CSV)

GxP System Implementations

Project Management

Data Migration

Education

Bachelor’s or Master’s in Life Sciences

Training in Computer System Validation

Tools

Empower CDS

eQMS Platforms

Job description

(CSV) Quality Assurance Systems Specialist

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General Information

Title: QA Systems Specialist – eQMS & CSV Projects

Date: 30 Apr 25

Site: MedPharm Limited, Guildford, UK

Department: Quality Assurance

Reporting To: Director, Quality Assurance (UK)

Position Summary

QA Systems Specialist – eQMS & CSV Projects will lead and support the implementation, migration, validation, and ongoing management of key electronic Quality Management Systems (eQMS) and pharmaceutical computerised systems at MedPharm. This includes acting as a Subject Matter Expert on ETQ, MasterControl, and other digital tools used to manage pharmaceutical quality data, ensuring compliance with GAMP 5, Annex 11, and applicable regulatory standards.

Essential Functions

• Manage key Pharmaceutical Computerised System projects, delivering according to plan.
• Maintain a good working knowledge of Computer System Validation and its practical implementation.
• Lead and support migration to new eQMS platforms (e.g., MasterControl, ETQ), ensuring smooth transition and compliance.
• Act as SME for eQMS platforms, providing training, troubleshooting, and support.
• Own and manage system lifecycle documentation: URS, risk assessments, IQ/OQ/PQ, data migration plans, SOPs.
• Promote a culture of acceptance to change supporting company-wide improvements.
• Provide regular updates to Senior Management and stakeholders on risks, issues, and system developments.
• Assist employees working on Computerised System projects.
• Ensure adherence to GAMP5, Annex 11 & 15, GLP, and industry guidance during activities.
• Ensure key personnel are trained prior to new system implementation.
• Drive post-implementation reviews and continuous system improvements.
• Support QMS as SME on computer systems storing pharmaceutical data.
• Maintain compliance and audit readiness for electronic systems.
• Act as GLP Archivist and manage archiving processes.
• Mentor users and deliver training on validated systems.

Key Relationships

• Heads of Department
• Senior Management
• Quality Assurance
• External Contractors
• Vendors

Travel requirements

None

Education And Experience

• Bachelor’s or Master’s degree in Life Sciences, Engineering, Computer Science, or related discipline (desirable but not essential)
• Training in Computer System Validation or GAMP 5 (preferred)

Knowledge, Skills, and Abilities

• Experience with ETQ, MasterControl, or similar eQMS platforms (configuration, administration, training)
• Strong knowledge of CSV and GxP system implementations in regulated environments
• Hands-on CSV activities with Empower CDS, including validation, data migration, archiving, audit trails, user access, data integrity
• Success in leading system migrations or large-scale digitalisation projects
• Experience in validation documentation per GAMP 5
• Familiarity with eQMS and environmental monitoring systems
• Experience in Quality functions on computer system projects

Personal attributes

• Highly organized
• Effective communicator, translating technical concepts for non-technical users
• Strong project management and change control skills
• Able to influence and promote adoption of new systems

Physical Demands and Work Environment

While performing duties, physical demands may include sitting at a desk, using a computer, occasional standing, walking, bending, reaching, and lifting up to 10kg. Work is typically in a standard office environment.

Other Duties

Additional responsibilities may be assigned as needed.

Limitations and Disclaimer

This description is not exhaustive. Reasonable adjustments will be made for accessibility. Employees must possess the necessary abilities to perform duties proficiently.

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Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Quality Assurance

Industries

• Internet Publishing

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