| Remote Role CSV Specialist at Remote, Remote, USA |
| Email: [email protected] |
| Hi , I have a job opportunity for you if you are looking for new job you can call me on 248-306-8434 , or you can send me your updated profile at [email protected]. Job Role: CSV Specialist Location: Remote Job Description: System Validation, SAP Validation, Keywords CSV, Computer System Validation, SAP Validation, Product Serialization, DSCSA. Roles and Responsibilities: 10 years 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. (1.) Raising risks, issues and escalation to senior management and customer. (2.) To create all quality documents, collect metrics data and conducting Audits. To perform Value creation and KM activities. (3.) To create project plans and keep track of schedule for on time delivery as per the defined quality standards. (4.) To ensure process improvement and compliance, and participate in technical design discussion and to review technical documents. (5.) Co-ordination with On-Site Engineers and attending customer calls Warm Regards Shivi Sharma Technical Recruiter Tekshapers Inc 850 Stephenson Hwy, Suite 205, Troy, MI 48083 D: 248-306-8434 W: 248.565.4747 Ext. 134 Email: [email protected] MBE Certified | ISO 9001:2008 | * Disclaimer: This E-Mail may contain Confidential and/or legally privileged Information and is meant for the intended recipient(s) only. If you have received this e-mail in error and are not the intended recipient/s, kindly notify us at [email protected] and then delete this e-mail immediately from your system. You are also hereby notified that any use, any form of reproduction, dissemination, copying, disclosure, modification, distribution, and/or publication of this e-mail, its contents, or its attachment/s other than by its intended recipient/s is strictly prohibited and may be unlawful. Internet communication cannot be guaranteed to be secured or error-free as information could be delayed, intercepted, corrupted, lost, or contain viruses. Tekshapers. does not accept any liability for any errors, omissions, viruses or computer problems experienced by any recipient as a result of this e-mail. -- Keywords: information technology Colorado Michigan |
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| Fri Jan 12 21:18:00 UTC 2024 |