Home

JD - CSV || VALIDATION ENGNEER FOR (HYBRID) ROLE AT NJ at Raritan, New Jersey, USA
Email: [email protected]
Title:  CSV Consultant

Location:  Raritan, NJ , USA - Hybrid

Duration:  1 year

Mandatory Skills:  Computer System Validation, Quality Management System, Acquisitions and Mergers

Job Description:

Keywords
  CSV, Computer System Validation, Tools validation,  Quality Management System, 21 CFR 820, ISO 13485 ,

Acquisition and mergers

In addition to validation and regulation experience, the resource should have the following experience:

Roles and Responsibilities 

Minimum 

7  years
Experience in the Validating IT software systems like Quality Management System in Life Sciences industry

Experience in FDA and/or Global regulated environment with good understanding of GxP standards like CFR 820 and Risk based validation. 

Experience in validating Global Risk and Compliance modules

Provides consultation and counseling on Risk and Compliance module implementation in reference to regulatory quality

Knowledge of FDA guidance and industry standards

Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports
)

Experience in reviewing system test and user acceptance test scripts, Traceability matrix related to System data Archival process

Hands-on experience in software life-cycle management in System data archival process

Ability to provide Validation guidance, timely reviews, and escalations to Project teams

Thanks & Regards

Ayush Sharma

IT Recruiter

HMG America LLC

Ph No.+1 
732-790-5494

Email:[email protected]

www.hmgamerica.com

--

Keywords: information technology New Jersey
[email protected]
View all
Mon Jan 15 19:49:00 UTC 2024

To remove this job post send "job_kill 1013714" 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: 10

Location: Raritan, New Jersey