02 set - Rodano
Olon
Olon Group is a global leader in the development and production of active pharmaceutical ingredients (APIs) for CDMO and generic markets, integrating chemical synthesis and biological processes while always embracing the highest international safety, quality, and environmental standards.
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Olon operates 14 manufacturing sites and 14 R&D; centers across the globe.
In order to strengthen the IT team dedicated to Compliance, we are looking for an IT Quality, Compliance and Validation Manager.
Key Responsibilities
- Oversee the entire GxP systems validation lifecycle, ensuring that software and IT infrastructure operate as intended and in compliance with GAMP 5 standards and FDA 21 CFR Part 11 regulations.
- Develop and maintain validation procedures to ensure continuous alignment with current regulatory requirements.
- Prepare, execute, and approve validation protocols and reports (IQ/OQ/PQ).
- Identify, assess, and mitigate risks related to data integrity,
cybersecurity, and system performance.
- Provide IT support and quality assessments for deviations and non-conformities.
- Recommend, implement, and oversee corrective and preventive actions (CAPAs) to strengthen IT compliance.
- Author and maintain Standard Operating Procedures (SOPs) and work instructions related to IT system compliance.
- Ensure proper CSV processes during system implementations and offer CSV support for new IT projects throughout the entire project lifecycle.
- Support internal and external audits and inspections, manage interactions with regulatory authorities (e.g., FDA, AIFA), and ensure timely closure of findings through effective CAPA plans.
- Manage user profiling on validated systems, including documentation of profile creation, modification, and deactivation requests, technical implementation, and verification of compliance with requirements.
Required Skills (Hard &
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TITANIUM
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