Location: Zurich / Zug
Country: Switzerland
Role: Consultant, Subject Matter Expert
Team: Pharma/Medical Devices
Conception, planning and performing of Computer Systems Validation (CSV) in the regulated environment (Pharma, Medical Devices, Biotech)
Advisory and support of application owners to build and maintain GxP conform systems
Support and consulting during projects handling GxP critical computer systems
Implementation of qualification / validation activities within projects of new and existing computer systems according to our client requirements
Conception and implementation of Raw-Data-Handling systems and solutions (Data Integrity)
Computer systems according to internal Software Development Lifecycle
Performing internal and external CSV trainings
University degree in Informatics, Quality, Engineering or another relevant discipline
At least 2-3 years of experience in validation of GxP relevant IT systems such as ERP, MES, LIMS or Quality Systems
Working knowledge of national and international regulations and standards, eg. GAMP5, ISO 9001, ISO 13485, ISO 62304, FDA QSR, 21 CFR Part 820, Part 11
Analytical and structured working style; strong attention to detail
Ability to effectively work as part of a multidisciplinary, international team
Hands-on personality, with flexibility and dedication to maximize our client`s value
Fluency in English is required, German, French or Italian would be a plus
Please submit your online application in English or German language.
For further information, please contact our local Human Resources department.
At Consultys we want to make it easy for you to find and apply for a job, which is why we have listed here the most commonly
asked questions we receive regulary.
No, Consultys is neither headhunter nor a job agency. We are providing our clients local, operational, compliances services within an integrated team-approach. Consultys always owns the direct relationships to the responsible line manager(s) within the organization.
We offering our compliance services for LifeScience clients mainly in Switzerland, Germany, France and Belgium, locally.
In addition we are offering our Medical Device clients dedicated services in Product Certification and Mock-Inspections for the US market (FDA).
Consultys offers it`s compliance services, tools and solutions for LifeScience organizations of all sizes, from small start-ups, spin-offs (ETH, EPFL, …) to mid-size (KMU) and global companies with thousands of employees.
Once you apply to the position, you will be provided with an automatic email confirming that your application has been successful. Timeframes differ by team but you should expect an answer within a few weeks, usually this will be faster. Once you have applied for the first time, your profile will be stored in the system. You might be contacted by our recruiters or by our automatic matching tool of job opportunities of interest to you.
In any case, your resume/CV will remain in our database for up to 4 years and we might contact you during that time. If you would like to be removed from the database, please review the FAQ "How can I delete my profile from the Consultys Talent Pool listed below.
When applying for a position, your information will be made available to our recruiters. They will analyse your skills & experience and will compare it to the requirements of the position for which you have applied (as well as any other open position).
If we believe you match the requirements, we will contact you and, in a first phase, we will invite you for a telephone interview or physical interview (or videoconference interview); further interviews will be fixed when evaluated positively.