Job Description
Responsibilities:
Creates Computer System Validation (CSV) deliverables (Validation Plan, Requirements Specifications, Protocols, Summary Reports, Trace Matrices, SOPs, Risk assessments).
Collaborates with Business Users, System Owner, Global IT teams and Business Analysts to define validation requirements and plans.
Providing leadership, oversight, and training related to validation activities to multi-functional teams.
Generate and execute validation protocols (IQ/OQ/PQ) using Good Documentation Practices (GDP).
Ensuring that the quality system elements necessary to achieve and maintain compliance across multiple businesses, including regulated environments, are established and activities related to computer systems/software testing are controlled via these elements.
Working with appropriate teams to establish quality expectations related to validation planning and execution.
Participating wit...