Lead Consultant CSV - Remote / Telecommute

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Company: Cynet Systems

Location: Jersey City, NJ 07305

Description:

Job Description:

Pay Range: $55hr - $60hr
  • 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 document processes.
  • Compliance Analysis Adept with Agile and Waterfall methodology-based software development.
  • Compliance and has prior experience in Computer System Validation using Agile methodology.
  • ctivities Requirement Specifications, Functional Specifications User Stories.
  • cceptance 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.
  • ble 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 roles 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.

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