Trackwise Consultant

Ltimindtree

5 - 8 years

10 - 20 Lacs

Pune Bengaluru Mumbai (All Areas)

Posted:-1 days ago| Platform:

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Skills Required

Trackwise Gxp Quality Management QMS Implementation

Work Mode

Work from Office

Job Type

Full Time

Job Description

Trackwise Consultant

Experience: 5 to 8 Years

Location:- Bangalore/Pune/hyderabad

Notice period : Immediate to 15days

Job Description

Knowledge of Trackwise is a must
Should have indepth knowledge of handling Quality management in TrackWise
Should have a strong understanding of Trackwise Business processes such as Change Management System IncidentDeviation Investigation CAPA implementation etc
Should have a deep understanding of the individual workflowsapprovals in each Trackwise Module
Experienced in generating various types of queries in TrackWise requirements
Well versed knowledge of Quality Risk assessment through TrackWise Application
Should have managed QMS implementation projects including configuration migrations data migration multisite rollouts data archival etc
Should have adequate knowledge in performing gap assessments from an end user perspective
Need to ensure quality assurance procedures are followed and in accordance with Customers methodology and standards
Minimum 5 years of experience in a Pharmaceutical Life Sciences setting is preferred
Experience with industry standard and best practices regarding quality quality assurance and quality control principles and techniques eg 21 CFR Part 11 GAMP 5
Versed in health authority regulations such as FDA 21 CFR MHRA Annex 11
Subject Matter Expert in GxP GDP GLP GMP and Data Integrity

Mandatory Skills : Architecture Principle Design, Software Engineering and Design Architecture, Trackwise

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