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CSV Engineer || Raritan, NJ (Hybrid) || Max Rate $40/hr. on CtC (No negotiation) at Raritan, New Jersey, USA
Email: [email protected]
Greeting,

Hope doing well

My name is Ankit Kumar, a Sr.
Technical Recruiter with Silverlink Technologies. We
are looking for a suitable candidate for the position, I came across your
resume and found this a perfect fit for this role. I would appreciate it if you
can provide the best time and number to reach you to discuss this further

Role- CSV
Engineer

Location-
Raritan, NJ (Hybrid)

Client: HCL

Experience:
3+ years

 Max Rate $40/hr. on CtC (No negotiation) IF you comfortable with rate then share 

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

3-7 years of relevant experience; can
work independently and guide mentor Junior resources.

Experience in the Pharmaceutical,
biotechnology, or medical device industry with System Development Lifecyle
in Computer System Validation

Experience in FDA andor Global
regulated environment with good understanding of GxP standards and Risk
based validation. Knowledge of FDA guidance s and industry standards
(i.e., GAMP)

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 and Design Specs.

Experience in QA Methodologies,
designing, reviewing and approving Test Plans, systems and UAT test
scripts and Test procedures. Ability to Review Automated Test script
Strong verbal and written communication skills.

Ability to work as a team player, lead
a team or accomplish tasks without supervision. Ability to work with
remote teams and support several changes projects simultaneously.

Ability to provide Validation
guidance, timely reviews, and escalations to TQ management. Hands on
experience with validation of Data Solutions is preferred.

To develop and deliver detailed
solutions through consulting project activities

To perform qualitative andoror
quantitative analyses to assist in the identification of client issues and
the development of client-specific solutions

To work with the team in implementing
the solutions

To develop good practice and Serve as
a subject matter expert

To design and structure reports and
presentations that are appropriate to the characteristics or needs of the
audience

To develop knowledge
base by staying updated on industry best practices ,emerging trends and
creating re-usable components.

Thanks & Regards

Ankit Kumar

Team Lead

[email protected]

https://www.linkedin.com/in/ankit-kumar-6300111a1/

Silverlink 
Technologies Pvt Ltd

www.silverlinktechnologies.com

--

Keywords: quality analyst information technology New Jersey
CSV Engineer || Raritan, NJ (Hybrid) || Max Rate $40/hr. on CtC (No negotiation)
[email protected]
[email protected]
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Tue Sep 17 23:22:00 UTC 2024

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Location: Raritan, New Jersey