| CSV Lead Position at King of Prussia, PA (Hybrid - 2 days onsite a week) at King, Wisconsin, USA |
| Email: [email protected] |
| From: Pavan Kumar, Yochana IT [email protected] Reply to: [email protected] New Billing/ Potential/ Non- Exclusive Skills- Computer System Validation, LIMS Keywords CSV, Computer System Validation, LIMS, Lab Instrument Validation, Plasma related systems Roles and Responsibilities 7-10 years Experience in the Validating LIMS systems and SaaS systems Experienced in CSV activities in Lab related applications like LIMS, ELN, Lab Instruments and Equipment systems and has a clear understanding of various Lab systems and processes Perform Quality and Compliance documentation review for GxP and non-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 of the documentation process 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 Performs Change Requests Implement and Close Change Request which includes to check for the application controls and associated documentation process for end to end Change Request process Reviews and ensures that the Operational Procedure for the application is ready Ensures that the document deliverables are Attributable, Legible, Contemporaneous, Original and Accurate and if any e-Signatures are applied then they are applied as per the defined workflows 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 (1.) Co-ordination with On-Site Engineers and attending customer calls (2.) Raising risks, issues and escalation to senior management and customer (3.) To create all quality documents, collect metrics data and conducting Audits. To perform Value creation and KM activities. (4.) To create project plans and keep track of schedule for on time delivery as per the defined quality standards (5.) To ensure process improvement and compliance, and participate in technical design discussion and to review technical documents Keywords: information technology Colorado CSV Lead Position at King of Prussia, PA (Hybrid - 2 days onsite a week) [email protected] |
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| Fri Apr 19 22:27:00 UTC 2024 |