Urgent hire_CSV LEAD CONSULTANT

Position:CSV LEAD CONSULTANT
Location:King of Prussia, PA (Onsite)
Position type: 6+ Months Contract
Client:HCL
Job Summary:
Primary Skill-Computer System Validation, Computed system assurance, GAMP, GxP risk assessments, Change Management
Secondary Skill-JIRA Veeva Argus Agile and Waterfall methodology
10+ years’ Experience in Validating systems and Experienced in CSV activities in GxP 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 documentprocess Compliance Analysis Adept with Agile and Waterfall methodology-based software development Compliance and has prior
experience in Computer System Validation using Agile methodology
Activities  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
-Single point of contact for Geo and functional specific scope of services related to system assurance and compliance role including CSA, Val SME and test management.
-Responsible for Geo and functional specific 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 relationship with regional stakeholders including gathering and resolving feedback
-Review system assurance and compliance deliverables and guide team on daily basis”