32 CSV Compliance Lead Jobs in King of Prussia, PA
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Universal Health Services, Inc. - Corporate Office
King of Prussia, PA | Full Time
$55k-71k (estimate)
0 Months Ago
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CSV Compliance Lead
$120k-157k (estimate)
Contractor | IT Outsourcing & Consulting
2 Months Ago
Cynet Systems is Hiring a CSV Compliance Lead Near King of Prussia, PA
Job Description:
Pay Range: $60hr - $65hr
Responsibilities:
Pay Range: $60hr - $65hr
Responsibilities:
- 10years’ 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.
Job Summary
JOB TYPE
Contractor
INDUSTRY
IT Outsourcing & Consulting
SALARY
$120k-157k (estimate)
POST DATE
05/24/2024
EXPIRATION DATE
11/11/2024
WEBSITE
cynetsystems.com
HEADQUARTERS
ARCOLA, VA
SIZE
500 - 1,000
FOUNDED
2010
CEO
ASHWANI MAYUR
REVENUE
$50M - $200M
INDUSTRY
IT Outsourcing & Consulting
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