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Validation

Company:
Ellianse
Location:
New York City, New York, United States
Salary:
60000
Posted:
December 04, 2018

Description:

CSV Validation Analyst – 1

Location – Multiple locations

Job Description- Computer System Validation (CSV) (Pharma )

Job Specifications

•Specific experience working in reputed pharmaceutical company

•Require prior experience in creating Change Requests, Developing Validation Plan, test scripts, Summary Reports, Traceability Matrix and other validation project documents in the Pharmaceutical industry

•Sound knowledge on regulatory compliance. One or more of the following areas: CAPA, 21 CFR Part 11, GAMP, GMP, GLP, GCP, GVP, GxP, IQ/OQ/PQ and Computer Systems Validation (CSV)

•Experience working on applications related to Electronic Laboratory Notebook (ELN), CDS, LIMS, SDMS etc. related to Discovery and Drug Product Development areas

•Create and execute validation test scripts and document test results in accordance with standards (Manually or in HP Quality Center). Review and evaluate validation assessments for application systems/projects.

Job Responsibilities

•Initiate, drive and support validation efforts and deliverables for systems used for Discovery/Instruments/Clinical/Pre-clinical with minimal oversight

•Advise customer and TCS technical organization in validation specific questions

•Review and evaluate validation assessments for application systems/projects

•Ensures that validation project documentation is in compliance with company and legal policies and procedures

•Prior Experience with validation of Discovery/Instruments/Clinical systems preferred

•Create and execute validation test scripts and document test results in accordance with standards (Manually or in Quality Center)

•File validation documentation, following Quality Assurance Library guidelines

•Provide monthly reports on of validation activities in the organization to Validation SME and/or Manager

Call on 619-625-1284