It-gxp Application Support

1 week ago


Mumbai, Maharashtra, India RS Consultants Full time
Location

  • Mumbai, India
  • Experience
  • 4 Job Type
  • Full Time
Job DescriptionWe are hiring a IT-GxP Application support for a
German IT company. This will be
work from office and the office location is at
BKC, Mumbai
Total Experience

  • 46 Years

Location - Mumbai (BKC)

Department:

  • Corporate Information Technology Department

Educational Qualification:
BE/ B Tech/ M. Sc / MCA / MS/ MCA [with IT/ Systems]

Minimum Relevant Experience Required: 4 to 6 years Active Functional Support for DMS / QMS (Preferred TrackWise) system and Learning Management System (LMS) SABA Enterprise or other GxP Enterprise system.
Life Science & Pharma industry exposure must

Travel Requirements:
Should be ready to travel across the Globe as per the project requirement.

JOB OBJECTIVE
GxP Application Support Representative which handles: Documentum, TrackWise, LMS and other GxP enterprise system.

It involves functional support requiring investigation, assessment and resolution of support issues which may involve the design, build and modification, data objects, mappings, reports and transformations of GxP enterprise system.

Participate in Testing and Validation of Upgrade/Modifications and timely implementation of IT enterprise system.

Support IT Application site team to ensure day to day routine activities performed at site.

KEY RESPONSIBILITY AREAS / DEVELOPMENTAL EXPERIENCES
Functional knowledge of GxP System - Trackwise, DMS, LMS and other Systems.

Responsible for reviewing all support Documentation and aid in maintenance and resolution

Responsible for adequate service levels can be maintained.

Audit participations/ support for all regulatory audits like MHRA & USFDA across locations.

Support to Overseas site for GxP Enterprise system & availability of system as per SLA

JOB SPECIFIC COMPETENCIES
Communicate effectively with senior management and team members. Presents and discuss work results clearly.

Experience in Documentum 7.x, D2 4.5, LSQM 3.0, Brava 7.3., TrackWise system 9.4.0 and Learning Management System (LMS) SABA Enterprise release 7 update 2 and other GxP enterprise system

Documentum, TrackWise and LMS client issues troubleshooting.

Identify and record risks / issues and provide periodic updates to senior management.

Understand the project scope, team structure and roles and responsibilities.

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