GxP and Medical Device Compliance Services
 

Computer System Validation (CSV) Expert


Location:   Zurich / Zug
Country:    Switzerland
Role:           Consultant, Subject Matter Expert
Team:         Pharma/Medical Devices
 

Role & Responsibilities

  • 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

Position Requirements

  • 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

  • Good verbal and written communication skills in English, German language is a plus

 

At a glance - Working as a Consultys Compliance Expert
 

Prismond Group - At a glance
Consultys Group

Consultys is a LifeScience service company with diverse career opportunities. We link operational compliance, quality assurance, regulatory and own solutions in ways that master complex compliance challenges to help our Pharma, Medical Devices and BioTech clients in the regulated environment.
Prismond Group - Boost our career
Boost your career

A consultant position with Consultys boosts your career, as you benefit from interesting, hands-on compliance projects, internal and external trainings, 1:1 mentoring and the expertise of our passionate experts.
Perks and Benefits

Consultys offers a wide range of benefits and opportunities for your professional development. Flat hierarchies, consulting with a partnership approach and a close-knit family atmosphere are essential elements of our company culture. Whether you join us as an intern, a recent graduate or a senior hire, Consultys offers great perks and benefits.

Take Action - Apply Now.


Please submit your online application in English or German language.

For further information, please contact our local Human Resources department.

F.A.Q. for Applicants

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.

Is Consultys a headhunter / agency company? . . .

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.

In which countries Consultys is offering it`s services? . . .

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).

What is the typical size of Consultys clients? . . .

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.

You submitted your application. What is the usual timeframe you should hear from us? . . .

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.

What does the typical recruitment procedure look like? . . .

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.