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Computer System Validation (CSV) for IT applications in the Pharma industry
Ref No.: 18-50795
Location: Chicago, Illinois
Position Type:Contract
Start Date: 07/19/2018
JOB SPECIFICATION: - (Please ignore if not a good match)

Role : - Computer System Validation (CSV) for IT applications in the Pharma industry

Location : - North Chicago, IL
Interview : - Phone or Skype
Project Duration : - 10+ (to be incremented on annual basis)

Job Description:

Description of Department Compliance and Validation
Reporting To Service Delivery Manager
Grade/Job Level Proposed Validation (CSV) Consultant
Job Specifications (The minimum acceptable qualifications that the candidate must possess to perform the job successfully)
  • 5+ years of 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 Client 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
  • Ensures that project documentation is in compliance with Client's policies and procedures
  • Provide monthly reports on of validation activities in the organization to Validation SME and/or Manager
Experience Length 8+ years in total, 3+ years as validation consultant in Pharma industry
Experience (Critical Areas) Validation of IT applications for Pharma applications
Experience (Desired Areas)
  • Ability to manage multiple tasks and projects simultaneously, and to prioritize work, goals and tasks per the divisional and corporate objectives
  • Strong interpersonal and technical writing skills and the ability to interact across divisional boundaries
  • Having Information Technology (IT) background with experience in Quality/Regulated environment including SDLC
  • Ability to report results clearly and concisely. Sound reasoning and ability to quickly analyze and solve complex problems
    Experience with Client Quality Center (QC), Client QTP, Client ALM and SharePoint is preferred