validation expert in Rotkreuz

Richa Bali, Zurich IT Professionals
job type
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job details

rotkreuz, zug
life sciences
job type
reference number
richa bali, zurich it professionals
058 201 56 40

job description

Our client, one of the most renowned medical device company in Switzerland. They are looking for a Validation Expert (German Speaker) in their office near Zug , Switzerland


They  produces instruments and devices that have to pass a quality control, which is done automatically and mechanically. The Q&V Operations (Qualification and Validation) department is responsible, among other things, for checking the software and test systems provided by TechSupport. As a backfill in this team, we are looking for a validation expert with the aim of enabling long-term cooperation including a strong build-up of know-how.


Tasks:The area of responsibility is divided into two areas, each of which is weighted differently.The main tasks (80%) include:- Creation of test plans for testing the software and scripts that control test / inspection processes in production- Validation of test software and test scripts as well as Excel workbooks according to CSV(Computerized System Validation), which test procedures / results from the, ensure the production environment and connect it to databases- Qualification of test / inspection systems (custom built, consisting of various sub-systems)Secondary activities (20%):- Project coordination, collaboration, planning and coordination of priorities in meetingswith production and project managers from Operations Instrumentation in particular Orders for customized test systems from the TechSupport department as well as the instrument lines- qualification of equipment such as standard equipment, measuring equipment.- Planning, implementation of validation / qualification activities, measuring equipment      suitability and proof of measuring equipment capability- Documentation of validation / qualification activities according to the internal manufacturing process in accordance with valid specifications and project planning- Creation of risk analyzes for equipment / software / systems- Support and professional advice for operators and users of equipment / systems,Skills - Experience in writing test plans for software and scripts- Experience as a software developer - Good knowledge of mathematics, especially formula calculation for the independent review of the rules stored in the software (in Excel or other programs preferred by the applicant) *****- 3-5 years of experience in validation, qualification and CSV (Computer System Validation) - Very good command of spoken and written German (entire documentation in German)- Experience in the regulated GxP environment- Very good user knowledge in SAP - Abstract thinking for recognizing complex relationships- High technical understanding of test / process sequences 

If its an interest to you than please apply ASAP and can also give me a call on +41582015670, I will be happy to speak with you to share more details regarding the position.


Good wishes :)