||NEED***Validation Consultant - Medina, NY - 6 + Months - yaseen.m@terminalcontacts.com

Hi,

The below is an Urgent requirement with our client.. Share your Resume & details to yaseen.m@terminalcontacts.com.

Role: Validation Consultant

Location: Medina, NY

Duration: 6 + Months

Joining: Immediate

Interview: Telephonic & Skype

 

Job details:

 

• 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.

 

With Warm Regards ,

 

YASEEN MOHAMMED

Technical Recruiter,

Terminal Contacts LLC.,

Phone : (813) 333-1678

Fax :       (813) 354-2419

Email : yaseen.m@terminalcontacts.com

Yahoo IM: yaseen.mterminalc

 

www.terminalcontacts.com

 

Terminal Contacts LLC.,  is a global provider of IT recruitment, software development and IT services. We deliver a measurable delta in productivity, profitability, and shareholder value to the world's leading companies. Our Methodology enables clients to lower the total cost of ownership and meet their business objectives.

 

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