Senior QC Systems Specialist: Data Integrity & GMP Expert

Proclinical

Hatfield

On-site

GBP 60,000 - 90,000

Full time

3 days ago
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Job summary

Proclinical seeks a Senior QC Systems Technical Specialist to support laboratory electronic systems (LIMS and CDS) within a GMP-regulated QC environment. You will manage master data, assist with validation activities, and maintain qualification documentation to ensure data integrity and regulatory compliance.

In this role you will collaborate with QA, IT and external partners, drive system improvements, and contribute to continuous quality and operational excellence across QC activities.

Qualifications

  • Degree or equivalent in a scientific discipline.
  • Experience with QC laboratory electronic systems and their qualification/validation.
  • Experience configuring master data in LIMS/CDS within a regulated pharma setting.
  • GMP and data integrity knowledge is essential.
  • Excellent communication and stakeholder management abilities.
  • Ability to work independently and stay highly organized.

Responsibilities

  • Provide technical support for QC electronic systems (LIMS/CDS).
  • Maintain master data for QC systems and ensure data integrity.
  • Support deployment, validation and qualification of new systems.
  • Generate and review qualification/validation documentation.
  • Assist investigations, troubleshooting and issue resolution.
  • Develop SOPs, work instructions and training materials.
  • Support change control and system lifecycle management.
  • Respond to regulatory/compliance requests for laboratory systems.
  • Identify opportunities to improve system performance and user experience.
  • Champion electronic system best practices and data integrity.

Skills

QC Systems
GMP compliance
Data integrity
LIMS CDS
System validation
Stakeholder mgmt

Education

Degree in scientific discipline

Tools

LIMS
CDS
MS Office

Job description

Proclinical seeks a Senior QC Systems Technical Specialist to support laboratory electronic systems (LIMS and CDS) within a GMP-regulated QC environment. You will manage master data, assist with validation activities, and maintain qualification documentation to ensure data integrity and regulatory compliance.

In this role you will collaborate with QA, IT and external partners, drive system improvements, and contribute to continuous quality and operational excellence across QC activities.

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