| CSV Specialist-NJ*Remote-Immediate Interview-HCL at Remote, Remote, USA |
| Email: [email protected] |
| From: Danish Azeez, Inherent technologies [email protected] Reply to: [email protected] Position: CSV Specialist Location: NJ/Remote Duration: 1 Years Phone & Skype Client: HCL Immediate Interview *ITAP Reference number BR Number Candidates Details Full Name (First ,Middle, Last) Current Location (City & State) Relocation Authorization (H-1,GC,US Citizen, TN,OPT) Primary Phone Number Email ID SSN (Last 4 digit) DOB (MM/DD) Total IT Experience Total US Experience Vendor Name Salary / Hourly Rate Skill Rating Mandatory Skills Hands on experience in Years Last used -Year Self-Rating (Scale 1-10) 1. 2. 3. 4. Mandatory Skills CSV/ JIRA/ LIFE-SCIENCES (GXP, FDA, CSV, IQ/OQ/PQ)/ Agile- Waterfall/ DMS/ SAP Validation/ Product Serialization, US- DSCSA/ Life Sciences_Manufacturing/ ALM 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 Keywords: materials management information technology green card trade national Colorado Idaho New Jersey Tennessee |
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| Sat Jan 13 01:52:00 UTC 2024 |