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Computer Validation Specialist

vor 2 Monaten

Barleben, Sachsen-Anhalt, Deutschland D-ploy Vollzeit
About D-ploy

D-ploy is a leading IT and Engineering Solutions company with a strong presence in the EMEA region and the USA.

We pride ourselves on delivering innovative and superior services and solutions to numerous industry-leading clients. By building relationships and trusted partnerships within the IT community, we optimize our customer's IT productivity and contribute to the organization's success and value.

We are a dynamically growing and international organization, focused on creating value where IT counts.

Job Summary

We are seeking a skilled Computer Validation Expert to join our team. The ideal candidate will have experience in Computer Systems Validation (CSV) and a strong understanding of applicable regulations and standards.

Key Responsibilities
  • Define Validation Approach: Develop and implement a validation approach that aligns with CSV framework and other applicable regulations and applications.
  • Manage CSV Projects: Lead or support CSV projects with a focus on applications, working with internal employees and external consultants/vendors as needed.
  • Qualify Software Components: Manage or support the qualification of software components supporting regulated systems.
  • Provide Consultancy: Offer consultancy regarding CSV compliance within the Group IT and other stakeholders as needed.
  • Support Application Management: Support local Application Management Teams regarding validation and review tasks.
  • Participate in Audits: Support and participate in Group IT Quality-related Audits.
Requirements
  • Experience in CSV: Proven experience in the field of Computer Systems Validation (CSV).
  • Regulatory Knowledge: Good knowledge of applicable regulations and standards, including GAMP5, ITIL, and 21CFR11.
  • Project Experience: Experience working on projects.
  • Language Skills: Very good written and spoken English and German skills.
  • Communication Skills: Good communication, intercultural, and networking skills with the ability to work independently in a well-structured and systematic manner.
  • Problem-Solving Skills: Proactive and structured way of working, solution orientation, and a distinctive ability to work in a team.
  • Adaptability: Flexibility and ability to adapt in a fast-paced environment.
What We Offer
  • Broad Range of Activities: A broad range of activities, tasks, and projects.
  • Flexible Working Conditions: Flexible working conditions.
  • Generous Benefits: Minimum 5 weeks of vacation, paid sick days, meal vouchers, vouchers, contributions to wellness programs, and more.
  • Professional Advancement: Further development and professional advancement opportunities.
  • Friendly Environment: A friendly and international working environment.
  • Competitive Salary: Competitive salary and various benefits.