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IT Quality and Compliance Specialist

Arcondis Solutions s.r.o.

Information about the position

  • Place of work: Košice, Slovakia (Job with occasional home office)
  • Basic wage component (gross) and other rewards: 2 800 EUR/monthFinal salary will be agreed during the interview process based on your skills and experience.
  • Start date: upon agreement
  • Contract type: full-time

Job description, responsibilities and duties

As part of your daily work, you will:
• Oversee quality and compliance-related activities, such as validation, qualification, system risk assessments
• Provide consultancy to stakeholders regarding IT compliance, processes, and standards considering the dynamic agile IT environment
• Provide ongoing support of ITSM processes, e.g. Change- and Configuration management
• Consulting of system support & product teams concerning IT Quality Assurance and Compliance topics (such as CSV, GDPR, ICFR, etc.)
• Maintain components of the Quality Management System (SOPs, TOPs, Templates, Checklists, etc.)
• Collaborate to create the future IT Governance Framework with IT processes and standards to keep these updated with the newest developments of external standards and best practices
• Develop Validation plan and Validation summary reports.
• Contribution to the continuous improvement in IT regarding the regulatory environment

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
• 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

Information about the selection process

Please submit your application in English.
Thank you for applying to Arcondis!

Requirements for the employee

Candidates with education suit the position

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

Educational Specialization

IT and pharma

Language skills

English - Advanced (C1)

Experience in the position/sector

3

Number of years of experience

4

Personality requirements and skills

Must Haves:
• A bachelor's or master's degree in Business Informatics, Engineering, or the like
• Passionate about supporting and consulting IT delivery teams to strive for compliance in a collaborative way
• 3y+ of proven working experience in IT Quality Assurance functions (Validation Lead, Quality management, Auditing), ideally in the medical device or pharmaceutical industry.
• Basic knowledge of key regulatory requirements for CSV, Data Integrity, ICFR, GDPR, etc.
• Ability to cooperate and your power to convince a product owner or line manager
• Eager to monitor and automate IT quality processes as a basis for data-driven decision making
• You show excellent communication and coordination skills, a confident appearance and you have a systematic and strategic thinking
• Used in working in virtual, diverse global teams
• Excellent English speaking and writing skills and willing to occasional business travel

Advantage to have:
• Proven working experience in CSV and in Agile Frameworks (SCRUM, SAFe)
• Basic Experience with outsourced IT services (Offshoring, Cloud, Testcenter, etc.)
• Knowledge of IVDR in EU, FDA QSRs, ISO 13485, ISO 14971

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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