Roles and Responsibilities – Regional System Assurance Lead

• 10 years Experience in Validating SAP systems in Manufacturing Experienced in CSV activities in Manufacturing related applications like SAP Systems, Product Serialization systems, MES systems.
• Perform review for GxP systems to ensure compliance with regulatory requirements Working knowledge on end-to-end validation of GxP applications and is able to perform document/process.
• Compliance Analysis Adept with Agile and Waterfall methodology-based software development Compliance and has prior experience in Computer System Validation using Agile methodology.
• Reviews - Requirement Specifications, Functional Specifications/ User Stories /Acceptance Criteria and ensures completeness of test script with traceability.
• Ensures Risk Assessment is completed for all the requirements and test cases are designed in reference to the risk levels identified for the requirements.
• Performs review of pre-executed test protocol which includes all the basic elements of a test script, completeness and appropriateness of the test case to the requirement
• Ensures pre-executed test protocol has the necessary test data requirements to run the tests Reviews post-executed test protocols for the completeness, accuracy of the results and evidence and enables team on the defect management process
• Able to author Validation Plan and compile Validation Summary Report and generates RTM Reviews and ensures that the Operational Procedure for the application is ready
• Is able to handle Change Requirement related implementation for small changes - responsible for Implementation Plan, Impact Assessment, Test Plan/ Results, Defects and RTM Prior experience in using tools like ALM, DMS and JIRA
• Good to have experience in implementing US-DSCSA

Job Type: Contract

Pay: $55.00 - $60.00 per hour

Experience:

• SAP Validation: 10 years (Preferred)
• Computer System Validation: 10 years (Preferred)
• Product Serialization: 5 years (Preferred)
• DSCSA: 3 years (Preferred)
• GXP Systems: 5 years (Preferred)
• MES systems: 10 years (Preferred)

Ability to Commute:

• King of Prussia, PA 19406 (Preferred)

Work Location: In person