Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & 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:
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.