Lead Validation Consultant job – Foresight Group International AG – Parsippany, NJ

Location

Parsippany, NJ

Job Type

Full-Time Regular

Job Description

JOB DESCRIPTION

VALIDATION CONSULTANT

FORESIGHT PRACTICE AREA

VALIDATION ( 00i)

ROLE DEFINITION

Involved in the complete life cycle of validating Pharmacovigilance / Drug Safety Adverse Event Reporting Systems at life sciences clients, which includes the analysis of Business and Functional requirements, assessing and mitigating Risks, planning for Validation approach and Test Strategy, developing Trace Matrix, developing and executing Validation Scripts, Defect Management and preparing Validation Summary Report.

JOB DUTIES

 Provide application validation expertise on Adverse Event Reporting products including Argus Safety, ArisG, Oracle AERS, Clintrace and related modules

 Be accountable for authoring Validation Plan, Traceability Matrix and Validation Summary Reports

 Requirements Analysis and Risk Assessment, Profiling and Mitigation

 Development, Execution, Approval and Monitoring of the Qualification ( IQ, OQ, MQ, PQ scripts and protocols, results and reports) deliverables for GAMP Software categories

 Follow the cross-phase procedures and plans like Defect Management Plan, Change Control Procedure, Document Management Plan and Training Plan

 Closely work with clients and vendors to support implementation and resolve product issues

EDUCATION AND OTHER QUALIFICATIONS

 BS degree

 Previous computer systems validation experience, ideally with drug safety systems.

About secureteam

secureteam
A Computer Programmer whose articles got mentions from the likes of The New York Times, Kissmetrics and AllTopStories. He writes articles, novels and poems; spends most of his time reading everything he could get his hands on. He is currently pursuing his Masters from The University of Illinois and holds a Bachelors in Electronics Engineering from the University of California. He is a programmer, a motivational writer and speaker.

Leave a Reply

Your email address will not be published. Required fields are marked *