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Roche: Quality & Compliance Specialist (CSV, GMP, GCP) (Warszawa, Poznań)

Oferta archiwalna

Quality & Compliance Specialist (CSV, GMP, GCP)

Bezpośrednia
  • Roche
  • Warszawa, Poznań
  • 29.08.2025

Podsumowanie oferty:

  • Branża

    Opieka zdrowotna / MedTech / Nauki biologiczne
  • Rodzaj umowy

    UoP
  • Doświadczenie

    Mid
  • Technologie i Narzędzia

    GCP, CSV, GMP, Quality Assurance, Compliance, Computer Systems Validation, Regulatory Standards, GxP

Opis oferty:

Quality & Compliance Specialist role at Roche focusing on delivering quality and compliance in IT systems throughout their lifecycle. The company aims to prevent, stop, and cure diseases while ensuring access to healthcare for all.

The position involves assuring that Roche's regulated systems adhere to standards like CSV, GMP, GCP, and managing regulatory risks. It includes participating in the development of standards related to Computer Systems Validation, providing consultation on Roche's CSV approach, and overseeing IT systems compliance. The role also involves stakeholder management, shaping product direction, and ensuring compliance with regulations.

Roche is dedicated to advancing science with over 100,000 employees globally, treating millions with their medicines and diagnostics products.

Wymagania:

  • Experience in Quality Assurance and compliance in IT systems
  • Knowledge of regulatory standards like CSV, GMP, GCP
  • Experience with Computer Systems Validation
  • Ability to manage regulatory risks
  • Knowledge of GxP, data privacy laws, and regulations

Dodatki i korzyści:

  • Opportunity to work in a company dedicated to healthcare innovation
  • Collaborative and open culture
  • Focus on personal and professional growth
  • Contribution to preventing and curing diseases
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