Freelance_Data Analyst Scientist Developer
The FDA published 2012 a new guideline regarding the continuous process verification ofpharmaceutical products. The guideline requests the proof of broad process knowledge andimplementation of a 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 performprocess trouble shooting. The basis of a good process analysis is a broad data volume regarding theproduct quality and manufacturing process. The Global Data Trending Solution (BI-AS-GDTS) serves the purpose to consolidate, transform andmerge all corporate-wide available electronic data regarding product quality, manufacturing processand enterprise resource planning into a common data pool. Therefore it is necessary to establishindividual interfaces to several data sources and to grant a general access to the aggregated data forGDTS. Since the data will be used for GxP-relevant trending and reporting the GDTS relevant INFORMATICA workflows implemented on the INFORMATICA infrastructure system (current version 10.4) has to be validated.
Tasks:
1. Informatica Workflow enhancement GDTS Release 3.0 – MyLIMS
a. Create technical mapping documentation with defined and delivered requirements which is needed for validation documentation for GxP system AS-GDTS
b. Enhance GDTS Informatica framework for new global source system MyLIMS
c. Develop mapping (interface) for analysis data (CQA) in corresponding workflows
e. Development testing for newly created interface in already existing testing system and GDTS environment as needed for GxP system AS-GDTS
f. Create or Update GDTS Validation IT documentation in 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 process
2. Informatica Workflow enhancement GDTS Release 2.0 – GBS United
a. Existing GBS interface needs to be extended with additional source qualifier fields to enhance existing CQA data structure.
b. Create technical mapping documentation with given template documentation which is needed for validation documentation for GxP system AS-GDTS
e. Development testing for adapted interface in already existing testing system and GDTS environment as needed for GxP system BI-AS-GDTS
f. Create or Update GDTS Validation IT documentation in 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
3. Informatica Workflow enhancement GDTS Release 3.0 – MES
4. Review, redesign and rework of the existing Informatica framework
Qualifications:
- Mind. 3 years experience of Informatica development and implementation in projects
Know-How:
Informatica Senior Consultant / Certified Developer
Business Intelligence
Data Warehouse Design und Architektur
Database modelling and -integration
Methods&Processes:
Data analyse
Data base modelling
Technical Expertise:
Data Warehousing – ETL – Informatica (Version 10.2/10.4)
