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Hiring For CSA Validation engineer, onsite in Indianapolis at Indianapolis, Indiana, USA
Email: [email protected]
Title:- CSA Validation Engineer

Indianapolis (Onsite)

Computer Software Assurance Validation Engineer

3 months project with a high chance of extension

Expert in
CSA validation principles.

Develop a strategy to convert existing
CSV approaches to lab validation into a

CSA documented process.

Developing, reviewing, and executing testing documentation.

Direct experience and understanding of complex lab systems such as HPLC, GC, TOC, UV/Vis, Plate Readers and automated titrators

Hands on experience with lab techniques and general lab analytical operations.

Understanding of baselined lab standards and system suitability verification.

Basic experience with IT system formats, configurations, and workflows.

General understanding of the business processes supporting one or more domains, such as: Clinical, Quality System Management, Commercialization.

Create and revision of all IT
CSV project and system deliverables including but not limited to:

Plans

Requirements

Specifications

Test Protocols, Scripts and associated execution deliverables (such as test incident reports, etc.

Summary Reports

Change Controls

Review system operational and administration procedures to ensure they are adequate

Document any findings of non-compliance

Assist with strategy regarding remediation activities

Assist with review of remediation activities

Must be willing to work onsite in Indianapolis, IN

Strong understanding of
CSA principles and how to leverage them in a lab validation setting.

Experience in pharmaceutical
cGxP setting with the ability to generate

CSV deliverables with support of mentor.

Act as the Subject Matter Expert on various pieces of lab equipment

Demonstrated experience in leading lab CSV activities specific to Process Equipment

Ability to work as part of a team.

Experience in
GMP
regulated environment.

Proven attention to detail and organization in project work.

Capable of working on assigned tasks without mentorship.

Demonstrated ability to generate CSV deliverables independently.

Thanks & Regards

Manish Kumar

Sr. Technical Recruiter

Email:        
 [email protected]

Linkedin:
   Manish Chaudhary Jaat | LinkedIn

ANVETA, Inc

Address: 1333 Corporate Drive, Suite #108 Irving, TX 75038, USA

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Keywords: information technology green card Texas
Hiring For CSA Validation engineer, onsite in Indianapolis
[email protected]
[email protected]
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Mon Oct 28 22:20:00 UTC 2024

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