Data Integrity QA Validation Engineer - Katalyst Healthcares and Life Sciences : Job Details

Data Integrity QA Validation Engineer

Katalyst Healthcares and Life Sciences

Job Location : Rensselaer,NY, USA

Posted on : 2025-01-31T08:02:26Z

Job Description :
Responsibilities:
  • Participate on teams of internal resources in delivery of CSV projects.
  • Author functional requirements specifications that are complete, accurate, and testable.
  • Author system Risk Assessments, 21 CFR 11 Assessments, and Annex 11 Assessments.
  • Author Validation Plans and Validation Reports.
  • Author validation and verification testing protocols/scripts (i.e., IQ, OQ, PQ) and Trace Matrices.
  • Experience in validation at least two of these computer system categories: automation control, laboratory systems, quality management systems, ERPs, clinical trial and pharmacovigilance applications.
  • Experience in validation of multiple system delivery models including SaaS, PaaS, IaaS, and On Prem.
  • Working knowledge of software testing techniques and test case development best practices.
  • Working knowledge of FDA 21 CFR 11, EU Annex 11 and supporting guidance documents.
  • Working knowledge of industry best practices such as GAMP5, ANSI standards (S-95, S-88), and ASTM (E2500).
  • Able to work effectively with local and virtual team members and other professionals, such as QA specialists, software developers, and system users.
  • Effective written and oral communication skills; ability to write, type, express or exchange ideas of a technical nature by means of the spoken word; convey information/instructions accurately; receive detailed information through oral or written forms and to translate those instructions into physical execution of tasks.
Requirements:
  • AS or B.S./B.A. in Software Engineering, Computer Science, Information Technology, or a related field.
  • Minimum 2 years of experience in the field of Computer System Validation.
  • Minimum 2 years of experience in Pharmaceutical, Medical Device, Clinical Research, or Healthcare Industries.
  • Execute validation and verification testing protocols and document results
  • Author SOPs for User Operation, System Administration and Maintenance, Back-up/Recovery, and Audit Trail Review
  • Prepare project status reports for clients and ProPharma management
  • Extensive travel may be required at times.
  • Other duties as assigned.
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