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.
<...