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