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 Lead the delivery of 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 to optimize laboratory operations and data management.
Provide Data Integrity (DI) and Computer System Validation (CSV) services for quality control (QC) equipment and system introductions.
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, specificatio...