Regulated IT Specialist

5 dni temu


Gdańsk, Pomerania, Polska LEO Pharma Pełny etat

About the Role

We are looking for a highly skilled IT Quality Assurance Key Expert to join our Corporate Quality team in Gdańsk, Poland. As a key member of our team, you will be responsible for driving quality initiatives and ensuring compliance with regulatory requirements.

Main Responsibilities:

  1. Participate in complex IT projects and drive initiatives that enhance our IT quality processes.
  2. Approve GxP documentation related to computerized systems, ensuring compliance with regulatory requirements.
  3. Serve as a key IT QA expert, addressing quality issues occurring in operation or as part of projects.
  4. Provide GxP support and collaborate with stakeholders to establish and improve procedures.
  5. Conduct GxP training and quality risk management activities.
  6. Oversee the IT QMS, performing compliance gap analysis, and approving GxP records.
  7. Participate in authority inspections and audits.
  8. Act as an internal/external IT auditor within GxP IT Systems.

Your Qualifications

To excel in this role, you will need:

  1. A Master's degree or similar in Computer or Natural Science.
  2. Minimum 10 years of experience within a GxP area and regulated IT activities, with expertise in compliance with 21 CFR Part 11, Annex 11, GAMP 5, ISO 13485, Data Integrity, ISO 9001, ISO 27001 (Information Security) & ISO 22300 (Security and Resilience).
  3. Profound knowledge of regulated IT activities and the pharmaceutical industry (within GMP, GVP, GCP).
  4. Comprehensive experience from the pharmaceutical industry and the ability to influence quality decisions taken by internal and external stakeholders.
  5. Proficiency in English, both written and spoken.
  6. Ability to handle complex issues and make decisions with a global perspective.


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