SAP Validation Consultant

Mandatory Skills

Computer System Validation, Computed system assurance, GAMP, GxP risk assessments, Change Management. 12+ years' experience in validating systems and experience in CSV activities in GxP related applications like SAP systems, product serialization systems, MES systems.

Responsibilities

• Perform reviews for GxP systems to ensure compliance with regulatory requirements.
• Work with end-to-end validation of GxP applications and conduct document/process compliance analysis.
• Adept with Agile and Waterfall software development methodologies; prior experience in Computer System Validation using Agile methodology.
• Prepare and manage validation activities including:
• Requirements Specifications
• Functional Specifications / User Stories / Acceptance Criteria
• Ensure completeness of test scripts with traceability
• Ensure risk assessment is completed for all requirements and that test cases are designed with reference to identified risk levels
• Review pre-executed test protocols for completeness and appropriateness of tests
• Ensure test data requirements are defined to run tests
• Review post-execution test protocols for completeness and accuracy of results; manage defects
• Author Validation Plan and Validation Summary Report; compile RTM; review that Operational Procedures are ready
• Handle change requirements for small changes: responsibility for Implementation Plan, Impact Assessment, Test Plan/Results, Defects and RTM
• Experience with tools such as ALM, DMS and JIRA
• Experience in implementing US-DSCSA is a plus

Role and Engagement

• Single point of contact for Geo and functional scope of services related to system assurance and compliance, including CSA, Validation SME and test management.
• Responsible for geo and functional service quality, performance and customer satisfaction; demand management.
• Perform CSL roles such as CSA, Validation SME, and Test Manager as required by CSL QMS.
• Build and manage relationships with regional stakeholders, including gathering and resolving feedback.
• Review system assurance and compliance deliverables and guide the team on a daily basis.