Business Analyst- GXP-GAMP5- must Speak German

Business Analyst - GXP - GAMP5 - must speak German

Working with IT and Computer System Compliance (CSC) partners on remediating computer systems at manufacturing plants

Work with and support eh Business Owners with the business deliverables for Computer System Validation of GXP including not limited to:

- Requirements Identification and documentation
- System Test Scripting
- System Test execution
- UAT Test Scripting
- Writing of Work Instructions/Procedures

Work with IT and CSC in planning of validations of GXP systems.

Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations

Knowledge in technical skills like Technical Writing is requested.

You should have the following Requirements:

- Higher Education (Engineer or similar) and background in Computer System Validation and at least several years work experience
- Responsibility in similar management position or extended experience as executer required.
- Knowledge of national and international regulations and standards, eg GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFRPart 820, Part 11
- Familiar with med. device manufacturing plants, SDLC
- Must speak Fluent English and German any other language skills is a plus

For more information please contact me.

In accordance with the Employment Agencies and Employment Businesses Regulations 2003, this position is advertised based upon Skillsearch Limited having first sought approval of its client to find candidates for this position. Skillsearch Limited acts as both an Employment Agency and Employment Business