Sr Associate, Quality Assurance Process Validation

09 ott - Alanno
ALFASIGMA

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Sr Associate, Quality Assurance Process Validation

Alfasigma is a privately held global healthcare company founded over 75 years ago in Italy, where it remains headquartered today in Bologna and Milan. The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa.

Over three years ago, we embarked on a transformative journey to become a truly global innovative healthcare company with a leading focus on Gastrointestinal (GI) health. We have experienced remarkable growth, nearly doubled our revenues, expanding geographically, and integrating several key acquisitions. We have also evolved our portfolio, expanded into rare and specialty segments, and strengthened our pipeline and people's capabilities.

But our journey is far from complete In fact, this is just the beginning of a bold new chapter in Alfasigma's history.



We are committed to advancing innovation and leveraging our deep expertise to provide better health and a better quality of life for patients and consumers worldwide and expand our reach across diverse markets.

Scope of the Role

The Senior Associate, QA Operations & Validation supports the execution, oversight, and continuous improvement of Quality Operations and QA Validation activities, ensuring full compliance with GMP requirements, internal procedures, regulatory expectations, and Quality Agreements with external manufacturing partners.

The role is responsible for supporting Process Validation and ICH Q3D-related activities, managing quality documentation associated with batch release, and contributing to the effective management of quality events. This position plays a critical role in ensuring the continuity of QA activities related to batch release, product quality, and regulatory compliance while collaborating with internal stakeholders and external manufacturers.

Your Role

As Senior Associate, QA Operations & Validation, you will:
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