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Computer System Validation Consultant
Arcondis Solutions s.r.o.
Štúrova 27, Košice, Slovakia (Job with occasional home office)
full-time
ASAP
2 600 - 3 000 EUR/monthThe salary indicated is a tentative estimation and the final salary will be agreed after an interview, once we find out more about your experience, skills and personality.
Information about the position
Job description, responsibilities and duties
Hello, we are looking for new members for the Arcondis family. This is your chance to make healthcare better. This opportunity will allow you to:
- Advise clients as a project manager or project team-member in the conception and implementation of computerized software validation (CSV) projects, IT qualification projects and IT compliance projects in a regulated environment
- Advise clients as a project manager or project team-member in the commissioning, qualification and validation (CQV) of equipment, facilities or processes in a regulated environment
- Support training & coaching in the field of CSV, hardware qualification, compliance as well as CQV
- Implement compliance audit findings in the client environment
- Manage conception and implementation of quality management systems
Employee perks, benefits
• Business mobile (also for private calls) and laptop
• Company bonus (based on company financial results)
• Referral bonus depending on level of person referred
• Heath-/Dentalcare costs coverage (up to 250EUR/year)
• Allowance for foreign languages classes/sport and leisure activities (up to 200EUR/year)
• 3 sick days per calendar year
• 2 extra days off for your wedding
• Social events (team-buildings and team-dinners)
• Budget for certifications and trainings (e.g. free access to 7000+ video trainings on www.pluralsight.com)
• Home Office (anywhere in Slovakia) upon agreement (possibility to work from Arcondis office in Kosice)
• Flexible Working Hours
• Become part of an established company with a start-up mindset (Self-organizing, flat hierarchy)
• Ice Hockey Tickets Discount (HC Kosice home games)
Information about the selection process
Thank you for applying to Arcondis!
Requirements for the employee
Candidates with education suit the position
University education (Master's degree)
Postgraduate (Doctorate)
Educational Specialization
Language skills
Experience in the position/sector
Number of years of experience
Personality requirements and skills
- Academic training in the field of business informatics, engineering, pharmaceuticals or a comparable subject
- Experience from working in production, in Quality Assurance or in the IT
- Experience in performing multiple validations and / or hardware qualifications as a project member or project manager
- Very good knowledge of the underlying regulatory requirements (e.g. FDA, EU, GxP, ISO 13485, best practices GAMP5)
- Fluent written and spoken English
- Eager to learn
- Great communication skills
- Eager to work in different locations, including abroad
- Very good team player
- Delivering rigorous on projects and quality
Nice to have:
- Jira and Confluence experience
- Programming skills (C++ or C# or another programming language skills) to review Software codes as part of validation activities
Language skills:
- English - Advanced (C1)
- Fluent written and spoken German
Advertiser
Brief description of the company
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