Overview
On Site
Depends on Experience
Contract - W2
Contract - Independent
Skills
Validation Engineer
QA
Pharmaceutical Manufacturing
Biotechnology
and Medical device
FDA
EMA
ICH
ISO
GxP
Quality Plans
Test Plans
Risk Assessments
Job Details
Hello Professional,
Hope you are doing well.
This is Dharm from Sunray Corporation I found your resume suitable for one of the prime position with one of our client.
Please find below the job description and let me know if you would be comfortable with
Please find below the job description and let me know if you would be comfortable with
Role : QA Validation Engineer
Location : Cypress, CA
Duration : 9+ Months
Role Overview
- Experience in Pharmaceutical Manufacturing, Biotechnology, and Medical device companies
- Performed Computer System Validation of cloud/server-based systems
- Involved in Data Integrity Assessments, Process Improvements, Issue Resolutions and implementing deliverables for Deviations/CAPAs on GxP regulated systems.
- Performed design validation and verification efforts for hardware and software platform development (New Product Development),
- Ensuring compliance with GxP requirements (FDA, EMA, ICH, ISO).
- Reviewed and updated Quality Plans, Test Plans, Risk Assessments, and DHFs for SaMD lifecycle processes
- Served as Computer System Validation lead, developed strategies, and managed teams for implementation ofQMS system and non-product software systems Qualification
Dharm Sharma
SunRay Enterprise, Inc.
Phone: ext.244
(Fax)
Email:
URL:
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