Specialist Pharmaceutical Quality Systems
Core
Lead onboarding and configuration of laboratory digital tools across QC processes, ensuring workflows, templates, roles, and access align with operational needs and controlled documentation.
Role type
Specialist Pharmaceutical Quality Systems (Digital Systems Integration)
Builds
Validated laboratory digital systems and compliant QC workflows
Domain
Pharmaceutical Quality Systems / GxP / Laboratory Information Management Systems (LIMS)
Required skills
GxP compliance, Data Integrity (ALCOA+), Controlled Documentation, Stakeholder Collaboration, Issue Resolution, Audit Preparation
Preferred skills
Experience with GQCLIMS, 1Lab, MODA, Businessmap, SAP
Technologies
GQCLIMS, 1Lab, MODA, Businessmap, SAP
Responsibilities
Lead onboarding and configuration of laboratory digital tools; Act as liaison among laboratory staff, IT, QA, and project leadership; Develop and deliver user-focused training, SOPs, and controlled templates; Troubleshoot system onboarding and usage challenges; Ensure GxP aligned configuration and use across systems; Prepare evidence packages for internal/external audits and inspections
Seniority
Mid-level, hands-on specialist