CSV Validation Analyst

[JyothiK]

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