CSV - Compliance and Validation Testing Lead

3 weeks ago

King of Prussia, United States Recmatrix Consulting Full time

Job Title: Compliance Lead

Contract Duration: 6 months, extendable

Location: King of Prussia, Pennsylvania.

Working model: Onsite/Hybrid

Required Skills: CSV, SAP Validation, Product Serialization, DSCSA


Roles and Responsibilities:


  • Perform review for GxP systems to ensure compliance with regulatory requirements
  • 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 ensuring 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 to participate in the defect management process
  • Able to author a validation plan, compile a validation summary report, and generate 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


Qualifications:


  • 10 years’ Experience in Validating SAP systems in Manufacturing
  • Experienced in CSV activities in Manufacturing related applications like SAP Systems, Product Serialization systems, and MES systems
  • Working knowledge on end-to-end validation of GxP applications and is able to perform document/process Compliance Analysis
  • Prior experience in using tools like ALM, DMS and JIRA
  • It is good to have experience in implementing US-DSCSA
  • Bachelor’s degree in Computer Science, Information Technology, or a related field.
  • Certification in CSV, SAP, or related fields is highly desirable.
  • Excellent communication and interpersonal skills.
  • Strong analytical and problem-solving abilities.
  • Ability to work independently and in a team environment.

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