What are the responsibilities and job description for the Data Integrity QA Validation Engineer position at Katalyst Healthcares and Life Sciences?
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 :
