Description

Hello,

We are hiring Non-Product Software Validation Lead who enjoys working with Computer System Validation, and regulatory (e.g., CFR 820, Part 11, Annex 11) leadership, support, and guidance. and related Services.

Interested candidate can apply, OR you can refer a candidate and earn rewards up to 50,000 INR if they get hired.

 

- Non-Product Software Validation

​- 6+Yrs Experience

- Long term Contract

- Location- Remote

 

JD:

 

As a Validation Lead you will be expected to provide computer system validation and regulatory (e.g., CFR 820, Part 11, Annex 11) leadership, support, and guidance. You are responsible for developing, or directly supporting, the development of all computer system validation deliverables, in order to enable the timely and compliant implementation of, or changes to, quality system-related applications in accordance with applicable procedures. Their ultimate goal is the following validation procedures and ensuring validation protocols have been implemented appropriately and successfully.
 

* You will provide coaching and guidance to the App-Sys-Svc Owner and other team members on how to navigate and utilize the validation process and validation job aids effectively.
* You will oversee the development and proper completion of the validation documents required by procedures and specifically the Validation Plan.
* You will review and approve the required validation documents and deliverables as assigned.
* You will ensure that all validation deliverable records are published to a Quality Management System (QMS) repository. (e.g., Livelink, EtQ, SharePoint, etc.). This can be an application that manages requirements, testing scripts, results, etc.

Regulatory experience or knowledge
* CFR
* ISO
* Eudralex
* MDD (MDR)
* IEC

2 to 3 years of relevant experience

SDLC methodologies knowledge and experience
ITSM
Agile
Waterfall
PLC
PLM

Office tools, power users of any of the Office Suite?
Word
Excel
SharePoint
Power BI

Check global opportunity at www.iitjobs.com
 

Thanks,
 


 

Srigowri Murahari
 

Technical Recruiter | Iitjobs.inc
 

[email protected]

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