IT Quality Assurance Key Expert
3 dni temu
At LEO Pharma, we are dedicated to helping people achieve healthy skin through groundbreaking treatments. We invite you to join our Corporate Quality team in Poland, where you will play a crucial role in supporting and enhancing our IT quality processes.
You will independently perform quality support for complex tasks, drive projects with wide impact, and participate in highly complex projects. Your key responsibilities will include:
- Participation in highly complex IT projects.
- Approval of GxP documentation related to computerized systems, e.g., Change Control, Deviations, CAPA, Validation Plans, etc.
- Act as a key IT QA expert regarding IT quality issues occurring in operation or as part of projects.
- Providing GxP support and partnering with LEO stakeholders to establish and improve procedures.
- Conducting GxP training and quality risk management activities.
- Overseeing the IT QMS, performing compliance gap analysis, and approving GxP records.
- Participating in authority inspections and audits.
- Acting as an internal/external IT auditor within GxP IT Systems.
To excel in this role, you will need:
- A Master's degree or similar in Computer or Natural Science.
- 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).
- Profound knowledge of regulated IT activities and the pharmaceutical industry (within GMP, GVP, GCP).
- Comprehensive experience from the pharmaceutical industry and the ability to influence quality decisions taken by internal and external stakeholders.
- Proficiency in English, both written and spoken.
- Ability to handle complex issues and make decisions with a global perspective.
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