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We have an Urgent Opening Please go through and Let me Know your Interest.
Role : CSV Lead
Location : King of Prussia PA(Hybrid)
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
Thanks
Prisca
CSV Lead1csvN/AC2C,W-2,C2H,Contract,Contract Only,HourlyUnited StatesFull Time
Business Services
$104k-124k (estimate)
05/12/2024
05/17/2024
e-solutionsinc.com
ALBANY, NY
1,000 - 3,000
2003
MICHAEL MULLIN
$50M - $200M
Business Services
"Empowering Technology Services Founded in 2003, we are in our 19th year of structured growth. We are a talent-driven, talent acquisition company providing individual consultants, project teams, and strategic outsourcing services to clients in a wide range of industries. E-Solutions, Inc. is a certified minority-owned staffing firm spearheaded by industry experts. We offer award-winning solutions for the Global Talent Cloud. Our services include: Staff Augmentation IT Outsourcing Business Process Outsourcing We leverage our recruiting expertise to deliver high-end consulting services for a ...variety of engagements. E-Solutions, Inc. has developed a business structure with no boundaries, which means we work as one collective entity. Our MSP partners and end customers have recognized our commitment to a partnering supplier model enabling us to expand to our present feat: 8 Nations 32 Operational Centers 1800+ Workforce Revenue ~$100+ Million Top 10 vendor for $10 Billion System Integrator Our clients extend from Fortune 500s to IT Companies, and we're experts at finding the right combination of solutions & solutions to fit any company's unique environment. We place professionals in contract, contract-to-hire, permanent hire, and statement-of-work-based positions with industry forerunners and innovative start-ups. We partner with talent ranging from IT professionals to engineering to skilled trades and many more. Our vast experience has provided us with a depth of knowledge that spans across industries and technologies. The following are the industry verticals, which we serve:- BFSI ITES Healthcare Energy & Utilities Light Engineering Manufacturing Warehouse & Logistics Administrative & Support Services Disclaimer E-Solutions Inc. Provides Equal Employment Opportunities (EEO) To All Employees And Applicants For Employment Without Regard To Race, Color, Religion,
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