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Business Analyst: Validation, CSV, Medical Devices. German*
Eingestellt von Sentinel IT LLP
Gesuchte Skills: Support, Engineer
Projektbeschreibung
Business Analyst: Validation, CSV, Medical Devices,.GERMAN*
My client, a world renowned Medical Device company based in Switzerland is seeking a Business Analyst with at least 5 years computerized systems validation experience gained within a GxP environment.
The successful candidate will have fluent English and German language skills and experience in the following areas:
Computer System Validation:
Work with IT and Computer System Compliance (CSC) partners on remediating computer systems at manufacturing plants
Work with and support the Business Owners with the business deliverables for Computer Systems 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
Requirements:
Higher education (Engineer or similar) and background in Computer System Validation and at least 5 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
Familiarity with med. device manufacturing plants, SDLC (prefer J&J but can be flex).
Team Player, able to work in a flexible environment with diverse characters/instances with excellent communication and cooperation skills.
Minimal language skills:
English & German fluent
My client, a world renowned Medical Device company based in Switzerland is seeking a Business Analyst with at least 5 years computerized systems validation experience gained within a GxP environment.
The successful candidate will have fluent English and German language skills and experience in the following areas:
Computer System Validation:
Work with IT and Computer System Compliance (CSC) partners on remediating computer systems at manufacturing plants
Work with and support the Business Owners with the business deliverables for Computer Systems 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
Requirements:
Higher education (Engineer or similar) and background in Computer System Validation and at least 5 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
Familiarity with med. device manufacturing plants, SDLC (prefer J&J but can be flex).
Team Player, able to work in a flexible environment with diverse characters/instances with excellent communication and cooperation skills.
Minimal language skills:
English & German fluent
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges