Career Opportunity: Job Title: Compliance Lead
About CodeForce 360 Making a career choice is amongst the most critical choices one can make, and it's important for the choice to be calculated with factors such as a company's run of success since its inception and more. But, when you come across a company that has reputation proven with nothing but an illustrious run of success since the day it began, you don't need to think of anything else. That's precisely what some of our employees and prospective employees think when they came across CodeForce 360.
Position Overview Compliance Lead
Requirements: Must Skills: CSV, SAP Validation, Product Serialization, DSCSA Roles and Responsibilities: 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. How to Apply Job ID: JPC - 187089
For more information, please contact below: Andrew Lincoln
Qualified individuals will be contacted for an interview.
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