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Senior QA Professional in GxP
2 tygodni temu
Driving Quality and Innovation
About LEO PharmaLEO Pharma is a global leader in medical dermatology, committed 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.
Your Key Responsibilities:
- Participating in highly complex IT projects that require extensive expertise.
- Reviewing and approving GxP documentation related to computerized systems, including Change Control, Deviations, CAPA, Validation Plans, etc.
- Serving as a key IT QA expert regarding IT quality issues occurring in operation or as part of projects.
- Providing GxP support and partnering with 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.
The Ideal Candidate:
- 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.
