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Compliance Consultant / Computer System Validation

Arcondis AG

Information about the position

  • Place of work: Remote work
  • Basic wage component (gross) and other rewards: 2 800 EUR/monthThe salary indicated is a tentative estimation and the final salary will be agreed after an interview, once we will find out more about your experience, skills and personality.
  • Start date: 01.10.2021
  • Contract type: full-time

Job description, responsibilities and duties

Advice clients as a project manager or project employee in the conception and Implementation of software validation projects, hardware qualification projects and IT compliance projects in a regulated environment
Development, production and logistics for the pharmaceutical and medical technology industry
Implementation of IT compliance audits in the client environment
Client advice on the conception and implementation of new IT compliance requirements from the regulated environment as well as the conception and implementation of IT quality management systems
Conception and implementation of IT quality management systems
Training & coaching in the field of computer system validation (CSV), hardware qualification and IT compliance
Support in the acquisition of new clients and projects

Employee perks, benefits

Competitive salary and bonuses
Home office
Flexible working-hours
Growth opportunities
And many others …

Information about the selection process

The salary indicated is a tentative estimation and the final salary will be agreed after an interview, once we will find out more about your experience, skills and personality.

Arcondis is planning to setup its offices in Košice in Q4 2021 or Q12022 (also depending on the pandemic situation).

Until offices are setup, you can work fully remote from any place in Slovakia. Afterwards, you will be able to work partially from home as part of our benefits package.

The start date indicated for this position is the earliest possible one. It might shift to beginning of September 2021.

IMPORTANT: Please submit your application documents in English only and via the following link:
https://www.arcondis.com/en/positions/-computer-system-validierung/

We are looking forward to receiving your application!

Requirements for the employee

Candidates with education suit the position

University education (Bachelor's degree)
University education (Master's degree)
Postgraduate (Doctorate)

Educational Specialization

Medtech

Language skills

English - Advanced (C1)

Experience in the position/sector

3

Number of years of experience

5

Personality requirements and skills

Academic training in the field of business informatics, engineering, pharmaceuticals or a comparable subject
Experience in performing multiple validations and / or hardware qualifications as a project member or project manager
SAP R3 / SAP Hana experience is an advantage
Good knowledge of the underlying regulatory requirements like, FDA, EU, GxP, ISO 13485 and best practices (GAMP5)
At least 3 years of professional experience in the field of computer system validation and / or qualification of hardware as well as in IT compliance topics
Experience in setting up IT quality management systems in the pharmaceutical and / or medical technology field
Fluent English spoken and written
German is a big plus
Enjoyment of client service

Advertiser

Brief description of the company

ARCONDIS is in the Top 10 of Consulting Companies in Health Care & Life Sciences in Switzerland. We are a global professional services company with an exclusive focus on the healthcare and life science industries, with their particularly demanding requirements on quality and regulatory affairs.

We have been addressing challenges and solving problems for our clients in the areas of compliance, business processes, information technology, and digital transformation since 2001.

We create value through cross-functional, sophisticated delivery methodologies and intelligent implementation.

Our clients love to work with us because of our unique skillsets, our pragmatic approach, and our will to win.

We make healthcare better.

www.arcondis.com

Number of employees

150-199 employees

Company address

Arcondis AG
Christoph Merian-Ring
4153 Reinach
Switzerland
https://arcondis.com

Contact

Kontaktná osoba: Daniel Čarnoký
E-mail: poslať životopis