Beschreibung
To support a customer project, we are looking for a Business Analyst CSV (m/f)Responsibilities:
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 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
Qualification:
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.
Mandatory language skills: English & German fluent
Location: Solothurn (CH)
Project time scale: 3 months
Details about this project can be provided. Please don't hesitate to contact us.
If you are interested in this employment opportunity, please send your profile and information about your availability and hourly rate to
NEWS under www.twitter.com/SoftpaceGmbH
Softpace GmbH