| CSV Lead-KOP PA(Hybrid)***Day 1 Onsite***Immediate Interview-HCL at Remote, Remote, USA |
| Email: [email protected] |
| From: Danish Azeez, Inherent technologies [email protected] Reply to: [email protected] Position: CSV Lead Location: KOP PA(Hybrid) ***Day 1 Onsite*** Duration: 1 Years Phone & Skype Client: HCL Immediate Interview Need Details in below format only else will not consider the resume. LinkedIn Profile link , Education details, Contact number has to be on Resume : Candidate Name Contact No. Email ID Current Location Visa Rate Ex-HCL Candidate Details: iTAP BR# Candidate Reference No. Full Legal Name: First Name recorded in iTAP (Please share iTAP snippet) Middle Name recorded in iTAP (Please share iTAP snippet) Last Name recorded in iTAP(Please share iTAP snippet) Rate Consultant Location: Contact Number: Email ID: Interested to Relocate (Yes/NO): Skype ID: (Must) Work Authorization (Must): Validity of Visa (If applicable): Availability for Onsite: Earliest Availability to Join: LinkedIn Profile: (Must) Current and Last few employers: Skill Rating Mandatory Skills Hands on experience in Years Last used -Year Self-Rating (Scale 1-10) 1. 2. 3. 4. JD- Keywords CSV, Computer System Validation, Product Serialization, DSCSA Roles and Responsibilities 10 years Experience in Validating SAP/N systems in Manufacturing Experienced in CSV activities in Manufacturing related applications like SAP/Non 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 readyIs 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 Keywords: Idaho Pennsylvania CSV Lead-KOP PA(Hybrid)***Day 1 Onsite***Immediate Interview-HCL [email protected] |
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| Fri Apr 05 23:50:00 UTC 2024 |