Job Details

• Developing necessary configurations and new work flows using LIMS basics and other development tools for enhancement in the existing functionalities implemented.
• Understanding and identifying the need of new enhancements in existing functionalities and exploring the possibility of designing it in Labware LIMS.
• Preparing the design document for the respective enhancement's to be developed / configured.
• Performing the impact assessment for the change to be done and its risks mitigation to avoid any cross impact on the already implemented functionalities.
• Developmental testing of the functionality developed / configured to ensure that its configured as per user requirement Resolving queries raised during the unit testing done by validation team in test environment and in validation environment.
• Creation of the configuration packages as per respective change requests and helping for necessary installation of the same in the intended environment.
• Development of crystal reports as per new functionalist configured/ enhancements introduced. Understanding the requirement of the report configuration in alignment to business requirement for new reports / changes in the existing reports.
• Designing the crystal report with applicable query tag, subroutines and the user dialogues.
• Developmental testing of the report developed and preparing/ installing the configuration package for the same.
• Trouble shooting and report resolutions for the queries raised
• w.r.t. report in use/ developed..
• Provide technical and regulatory audit support to end users by onsite or remote assistance to ensure smooth functioning of the new configurations -done/ enhancements introduced. Resolve technical queries related to LIMS raised by end user and auditor.
• Perform the trouble shootings for the errors / unexpected behavior form the system notified by end user, to identify the root cause.
• Taking necessary steps to configure the solutions for such errors reported and completing its necessary testing , documentation and implementation of the same, with necessary impact assessment.
• Designing new generic analysis, format calculations and subroutines to automate the tests (analysis). Understanding the generic analysis requirement as per business need/ specifications.
• Configuring the generic analysis, its testing and verification as per procedure defined.
• Validate computerized system to ensure that the system is in the validated state throughout its life cycle to use in a regulatory environments alike pharmaceuticals. Should aware about the CSV requirements, 21 CFR part 11 and GAMP 5 expectations along with EU annex 11 requirements.
• Prepare qualification and validation documents.
• Execute qualification and validation activity of computerized system.
• Review of qualification and validation documents.

• Total of 9+ in Labware system configuration, support, validation activity of out of which
• With detail knowledge on Labware V6 and should know about the capabilities of V7.
• Preferably should be Labware admin 2 certified candidate.
• Should have experience in instrument connectivity with labware LIMS and necessary script writings.
• Strong in SQL and LIMS basic knowledge with Labware system.
• Preferably Should have the basic pharma domain knowledge

Reference ID - GH/PHL/JC//28052019//84123/Manager & Senior Manager - LIMS