Senior Business Analyst (w/m/d) with experience in Computerized Systems Validation (CSV)

Beschreibung

Tätigkeitenbeschreibung
For our client within the Life Sciences Industry we are looking for a Business Analyst (w/m/d) with experience in Computerized Systems Validation (CSV).

Start: 12.10.2020
End: 31.12.2021
Fulltime
Onsite in Ingelheim

Background:
Biologic and Biochemistry Assays are run in numerous departments in numerous locations where the Calculation Biological Assays (CBA) Application is used.

For example, for the determination of antigen specific antibody titters and for the quantification of antigens in aqueous solutions or formulated in vaccines raw data must be processed using manual calculations or are processed by computer programs.

CBA is designed and built to accommodate these calculations. The system will take manual and equipment raw data as the input data, perform the required calculations and report this in a PDF as well as an excel file.


Tasks:
- Evaluate the excel spreadsheets and calculations and write the requirements in close collaboration with the business
- Understand the business process and the calculations used in the macros working in close collaboration with the development team
- Evaluate (macro) calculations in the spreadsheets and define the requirements for the integration into CBA in close collaboration with the development team (R and RShiny, Phyton)
- Define priority and bundles
- Coordinate and create plans for integrating the Excel sheets into CBA in close collaboration with the program manager
- Perform risk assessments and SDLC documentation (Requirement Specification, Test Scripts, etc.)
- Conduct Developer and User Test
- Hand over and training
- Conversion of code would be performed within the technology abilities offered by the suite of RShiny and R. Limitations if any would be informed to the MSD stakeholders
- Communication and project governance will be performed using Excel sheets, email, and SharePoint
- Onsite coordination and communication on progress and activities

Skills:
- Very good problem-solving skills working closely with the business areas in an interdisciplinary team
- Experienced with Computerized Systems Validation;
- Familiar with the pharmaceutical industry, laboratory area;
- Familiar with GLP, GMP writing the documentation and coordinate reviews by IT, Business and Quality;
- SDLC processes (System Development Lifecycle);
- Planning and coordination of the project using agile project management methodologies
- Experience with document management platforms like documentum
- Good communicative properties (ENG, GER);
- Proactive and used to work remotely in interdisciplinary teams
- Good knowledge of IT configurations of Computerized Laboratory Systems and Spreadsheets.

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Please get in touch with us via Mail.

Your contact:

Benjamin Walker
Nemensis AG | Hamburg
benjamin.walkerATnemensis.com