Must have skill(s): CSV, SAP Validation, Product Serialization, DSCSA

Location: King of Prussia, PA (Onsite/Hybrid)

Roles and Responsibilities Compliance Lead

1. 10years Experience in Validating SAP systems in Manufacturing

2. Experienced in CSV activities in Manufacturing related applications like SAP Systems, Product Serialization systems, MES systems

3. Perform review for GxP systems to ensure compliance with regulatory requirements

4. Working knowledge on end-to-end validation of GxP applications and is able to perform document/process Compliance Analysis

5. Adept with Agile and Waterfall methodology-based software development Compliance and has prior experience in Computer System Validation using Agile methodology

6. Reviews - Requirement Specifications, Functional Specifications/ User Stories / Acceptance Criteria and ensures completeness of test script with traceability

7. Ensures Risk Assessment is completed for all the requirements and test cases are designed in reference to the risk levels identified for the requirements

8. 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

9. Ensures pre-executed test protocol has the necessary test data requirements to run the tests

10. Reviews post-executed test protocols for the completeness, accuracy of the results and evidence and enables team on the defect management process

11. Able to author Validation Plan and compile Validation Summary Report and generates RTM

12. Reviews and ensures that the Operational Procedure for the application is ready

13. Is able to handle Change Requirement related implementation for small changes - responsible for Implementation Plan, Impact Assessment, Test Plan/ Results, Defects and RTM

14. Prior experience in using tools like ALM, DMS and JIRA

15. Good to have experience in implementing US-DSCSA