GxP Systems and Support Administrator
Core
Lifecycle administration of GxP and Quality governed systems (eQMS, CMMS, Digital Validation) within a professional services firm.
Role type
Mid-level GxP Systems Administrator
Builds
Validated IT systems and digital validation applications for pharmaceutical, biotech, and medical device clients
Domain
Life Sciences / Regulated IT / Quality Management
Required skills
GxP system administration, change control & validation, user access management, incident investigation, CAPA support, audit preparation, regulatory compliance (21 CFR Part 11, EU Annex 11, GAMP 5), cybersecurity basics, technical support
Preferred skills
CMMS/eQMS platform experience, professional services environment experience
Technologies
Dot Compliance eQMS, Master Control CMMS, Kneat, Valkit, Entra ID, SSO, SCIM
Responsibilities
Administer GxP applications and manage system configuration/upgrades; Perform user account administration and access reviews; Support Computer Software Assurance (CSA) activities including testing and periodic reviews; Execute system change controls and document validation procedures; Investigate and resolve system incidents and deviations; Support internal, supplier, and regulatory audits; Manage Tier 1 & 2 technical support; Assist in cybersecurity initiatives for regulated systems; Train end users on compliance requirements
Seniority
Mid-level, hands-on IC