Compliance Lead

3 weeks ago

King of Prussia, United States Themesoft Inc. Full time

Job Title: Compliance Lead

Location: King Of Prussia, PA (Hybrid Onsite)

Duration: Long Term Contract


Job Description:

- 10years’ Experience in Validating SAP systems in Manufacturing

- Experienced in CSV activities in Manufacturing 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 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,

Vignesh

vignesh.k@themesoft.com

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