Need.. "Validation Consultant"

Validation Consultant

Location: Medina, NY

JC 214703

6+ Months

 

Strong background in validating systems in a FDA regulated environment

Experience with validation of various systems including test script review and approval process .

Experience in FDA regulated environment with good understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards and Risk based validation.

Experience in Computer system validation.

Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, IQ/OQ and associated test scripts, and Validation Summary Packages )

Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs.

Knowledge of FDA guidance's and industry standards (i.e., GAMP)

Experience in HP Quality Center and QTP is preferable.

Understanding of the validation requirements and protocols including GAMP, 21 CFR part 11 and GMP

Should have done risk assessments such as 21 CFR Part11, GxP and Detailed risk assessments.

Strong knowledge in GAMP 5 software categorization and identifying the extent of testing as per the category.

Thanks and Regards

Sunny Mehta

Enterprise Solution Inc.

Direct :   630-246-6040

YIM :     sunnymehta89
Gtalk :   sunny.rectuiter2012

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