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• UG :- - Not Required

• PG :- - Not Required

• No of position :- ( 1 )

• Post :- 4th Mar 2021

Job description:

Summary: Responsible for LabWare Laboratory Information Management System (LIMS) design, implementation, management and support focused on environmental monitoring and product sampling. Must have experience within in a cGMP environment.

The LIMS system administrator will support the existing deployments of the LabWare LIMS system across 3 sites within Viral Vector Services (VVS).  The existing deployments are focused on environmental monitoring (3 sites) and product sampling (2 sites). 

Responsibilities:

* Design and implement approved enhancements, stored queries,  or crystal reports to support business operations already deployed on LabWare LIMS.

* Train and setup new end users on the use of the LIMS system

* Diagnose and troubleshoot issues raised by end users.

* Assist with investigations for deviations.

* Support regulatory audits or inspections as a system administrator / system expert.

* Assist in the development or maintenance of required documentation in a cGMP environment.

Requirements:

* BA/BS required in Life Sciences, IT related discipline or equivalent experience with 8+ years of appropriate work experience preferred.

* Knowledge of IT Control methodologies, including GAMP5 and solid understanding of GxP guidance, including 21 CFR Part 11, Annex 11 and Data Integrity.

* Knowledge of the computerized system lifecycle activities, CSV and IT controls in a regulated environment.

* Admin Certification in LabWare 7 is a plus.

* Strong communication skills, both verbal and written.

* Ability to work both independently and with teams at various levels in the organization.

* Ability to work in a very dynamic environment with a clear sense of urgency.

* Excellent organizational skills and attention to detail and accuracy.

* Experience supporting health authority inspections a plus