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

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

Job Description: Roles and Responsibilities Regional System Assurance Lead
10 years Experience in Validating SAP/N systems in Manufacturing
Experienced in CSV activities in Manufacturing related applications like SAP/Non 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

Regards Milind Sinkar Connect: 1 |