Developer (m-f-n)

The FDA published 2012 a new guideline regarding the continuous process verification of pharmaceutical products. The guideline requests the proof of broad process knowledge and implementation of continuous monitoring of parameters defined as critical process parameters. The Process Analysis is a main part on the path to achieve sound product knowledge and to perform process troubleshooting. The basis of a good process analysis is a broad data volume regarding the product quality and manufacturing process. The Global Data Trending Solution (BI-AS-GDTS) serves the purpose to consolidate, transform and merge all corporate-wide available electronic data regarding product quality, manufacturing process and enterprise resource planning into a common data pool. Therefore it is necessary to establish individual interfaces to several data sources and to grant a general access to the aggregated data forgets. Since the data will be used for GxP-relevant trending and reporting the GDTS relevant INFORMATICA workflows implemented on the INFORMATICA infrastructure system has to be validated.

Tasks:

Projekt: GDTS Rollout Wave 2b

The ongoing global project BI-AS-GDTS will be deployed and implemented to a next BI production location, Sant Cugat BI Spain.

Therefore the existing GDTS Informatica framework needs to be extended to load and transform the quality data out of the new source systems to the GDTS application system.

Already existent interfaces needs to be adjusted or modified like Mexico FreeweightNet and IBIS2007 system in the GDTS Informatica framework.

A newly introduced BI manufacturing system (Inmation) needs to be added to the GDTS Informatica framework.

An extended application monitoring on database level will be introduced and visualized via the reporting tool Tableau. Therfore a pilot needs to be set up and developed to production level.

Tasks:

1.   Informatica Workflow enhancement GDTS Spain- Sant Cugat Rollout

a.   3-4 new Quality source systems in Sant Cugat Spain to develop and implement into existing GDTS Informatica framework

b.   Create technical mapping documentation with given template documentation which is needed for validation documentation for GxP system BI-AS-GDTS

c.   Enhance GDTS Informatica framework for new plant id BI Spain Sant Cugat

d.   Develop mapping (interface) in Informatica for different source systems for analytical (CQA), manufacturing (CPP) and batch/material (ERP) data in corresponding workflows

e.   Development testing for newly created interface in already existing BI testing system and GDTS environment as needed for GxP system BI-AS-GDTS

f.   Create or Update GDTS Validation IT documentation in Boehringer documentation management system which will be reviewed and approved by internal GDTS IT members

g.   Informatica deployment of updated GDTS workflows from DEV to QA and PROD via defined Boehringer process

2.   Informatica Workflow modification Mexico FreeWeightNet interface

a.   Update technical mapping documentation with defined and delivered changes which is needed for validation documentation for GxP system BI-AS-GDTS

b.   Update/Modify GDTS Informatica workflow to exchange legacy FreeWightNet system to upgraded once

c.   Update FreeweightNet mapping (interface) for manufacturing (CPP) data in corresponding workflow

d.   Development testing for the changed interface in already existing BI testing system and GDTS environment as needed for GxP system BI-AS-GDTS

e.   Create or Update GDTS Validation IT documentation in Boehringer documentation managment system which will be reviewed and approved by internal GDTS IT members

f.   Informatica deployment of updated GDTS workflows from DEV to QA and PROD via defined Boehringer process

3.   Informatica Workflow enhancement IBIS2007 interface plant id 1199

a.   Update technical mapping documentation with defined and delivered changes which is needed for validation documentation for GxP system BI-AS-GDTS

b.   Enhance GDTS Informatica framework for new plant id BI Germany Ingelheim

c.   Develop mapping (interface) for analytical (CQA) and batch/material (ERP) in corresponding workflow on base of existing IBIS2007 interfaces

d.   Development testing for newly created interface in already existing BI testing system and GDTS environment as needed for GxP system BI-AS-GDTS

e.   Create or Update GDTS Validation IT documentation in Boehringer documentation management system which will be reviewed and approved by internal GDTS IT members

f.   Informatica deployment of updated GDTS workflows from DEV to QA and PROD via defined Boehringer process

4.   Informatica Workflow enhancement Inmation global source system

a.   Create technical mapping documentation with defined and delivered requirements which is needed for validation documentation for GxP system BI-AS-GDTS

b.   Enhance GDTS Informatica framework for new global source system Inmation

c.   Develop mapping (interface) for manufacturing (CPP) data in corresponding workflows

e.   Development testing for newly created interface in already existing BI testing system and GDTS environment as needed for GxP system BI-AS-GDTS

f.   Create or Update GDTS Validation IT documentation in Boehringer documentation management system which will be reviewed and approved by internal GDTS IT members

g.   Informatica deployment of updated GDTS workflows from DEV to QA and PROD via defined Boehringer process

5.   Introduce GDTS database enhanced monitoring visualized with Tableau

a.   Develop technical monitoring concept on base of the delivered technical specifications from the GDTS software vendor Trivadis in cooperation with GDTS IT System Lead

b.   Develop pilot dashboard in Tableau on base of point a)

c.   Create documentation of the project results for a handover to BI

d.   Implement final developed dashboard to production in cooperation with GDTS IT System Lead