Job Summary
Deliver laboratory equipment commissioning and qualification (CQ) and computer system validation (CSV) services to pharmaceutical and medical device clients, driving compliance and operational excellence through strategic implementation and technical leadership.
Responsibilities
Deliver laboratory equipment Commissioning and Qualification (CQ) services to pharmaceutical and medical device clients.
Implement laboratory enterprise systems such as LES and LIMS for pharmaceutical and medical device clients.
Author, review and approve Data Integrity (DI) and Computer System Validation (CSV) documents for quality control (QC) equipment and system.
Draft and review CQV and CSV documentation including User Requirement Specifications (URS), risk assessments, audit trail assessments, Electronic Records and Electronic Signatures (ERES) assessments, Installation/Operational Qualification (IOQ) protocols, specifications, and Requirements Traceability Matrices (RTM).