21 ago - Italia
Recordati
At Recordati, we are united by a clear purpose: unlocking the full potential of life. With a century of history behind us, we are building the next chapter of our journey, continuing to grow while keeping patients at the centre of all we do.
What drives us is a shared belief that health, and the opportunity to live life to the full, should be within reach for everyone. This brings energy to our work, shaping how we support each other and show up every day. Our values – Better Together, Never Settle and Always Deliver – reflect this mindset, helping us to keep improving and make a meaningful difference.
Above all, these values bring to life our promise to everyone at Recordati, you can unlock your full potential. We know that people thrive when they can be themselves, are trusted and supported, and are given the opportunity to grow and make a meaningful contribution.
Are you ready to unlock your full potential?
Job Purpose
Lo Specialista Assicurazione Qualità garantisce che i processi produttivi, analitici e documentali siano conformi alle normative vigenti (GMP, GDP, normative AIFA)
e agli standard di qualità aziendali.
The Quality Assurance Specialist ensures that manufacturing, analytical and documentation processes comply with applicable regulations (GMP, GDP, AIFA) and internal quality standards.
Key Responsibilities
- Garantire la conformità dei processi alle normative GMP e alle procedure interne
- Gestione Change Control
- Collaborare con Produzione, Controllo Qualità e Regulatory Affairs
- Revisionare anagrafiche e ricette (incluso il flusso degli Art Work)
- Revisionare Audit Trail di sistema e gestire aspetti di Data Integrity
- Revisionare Master Batch Record
- Supporto nella Scrittura di protocolli/report di convalida
- Effettuare indagini (deviazioni e/o reclami) e redigere i relativi report
- Ensure compliance of processes with GMP regulations and internal procedures
- Change Control Management
- Collaborate with Manufacturing, Quality Control and Reg
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