Home

JD - CSV || Validation Lead(HYBRID) AT PA ALTEAST 10+ YR EXPERINCE at Remote, Remote, USA
Email: [email protected]
Title:  CSV || Validation Lead

Location:  KOP PA(Hybrid)

Job Description:

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 & Regards

Ayush Sharma

IT Recruiter

HMG America LLC

Email: [email protected]

www.hmgamerica.com

--

Keywords: information technology Pennsylvania
JD - CSV || Validation Lead(HYBRID) AT PA ALTEAST 10+ YR EXPERINCE
[email protected]
[email protected]
View all
Sat Apr 06 04:26:00 UTC 2024

To remove this job post send "job_kill 1287216" as subject from [email protected] to [email protected]. Do not write anything extra in the subject line as this is a automatic system which will not work otherwise.


Your reply to [email protected] -
To       

Subject   
Message -

Your email id:

Captcha Image:
Captcha Code:


Pages not loading, taking too much time to load, server timeout or unavailable, or any other issues please contact admin at [email protected]
Time Taken: 74

Location: , Pennsylvania