Computer Systems Validation Supervisor
Core
Lead a team to deliver Computer Systems Validation (CSV) projects for analytical equipment, ensuring adherence to Quality and Data Integrity standards in a manufacturing environment.
Role type
Senior IC Computer Systems Validation Supervisor
Builds
Validated analytical systems and processes for pharmaceutical manufacturing
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Computer Systems Validation (CSV), Data Integrity, Quality Management Systems (QMS), Risk Assessment, Change Control, CAPA management, GMP compliance, Project Management, Team Leadership, Stakeholder Management
Preferred skills
Manufacturing operations knowledge, Process Improvement methodologies (RCA, FMEA, VSM), MS Office proficiency
Technologies
TrackWise, EDMS, MS Project, MS Excel, MS Word, MS PowerPoint
Responsibilities
Lead planning and execution of IQ/OQ/PQ validation plans; Manage QMS records and review EDMS documents; Coach and develop staff through performance reviews; Partner with OT, Engineering, and QA to ensure site-wide consistency; Identify quality concerns and drive issues to resolution; Handle administrative duties including task assignment and hiring.
Seniority
Senior, hands-on IC with team leadership
