CSV Lead Consultant

2 weeks ago

Jersey City, New Jersey, United States Katalyst Healthcares & Life Sciences Full time
Roles & Responsibilities:
  • 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 process.
  • CSV, Compliance and Assurance services, LIFE-SCIENCES (GXP FDA CSV IQ/OQ/PQ), Veeva, Argus, Defect Tracking Tools JIRA.
  • 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.

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