Sr associate, qa compliance

30 ago - Italia
Alfasigma

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. 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 Quality Compliance Specialist, reporting directly to the Quality Compliance Coordinator,



will be part of a team of three people and will play a key role in the management and continuous improvement of the electronic Quality Management System (e QMS). The role focuses on ensuring the effective management of training records, document control, procedural workflows, and the CAPA system, while maintaining full compliance with GMP requirements and internal Quality System standards. Working closely with Quality Assurance and other internal and external stakeholders, the position contributes to strengthening the company's quality culture and ensuring regulatory compliance across the organization. Your Role In this role, you will support the implementation, maintenance, and continuous improvement of the Quality Management System, with a strong focus on training compliance, CAPA management, and document control processes. Manage the training process within the e QMS, ensuring accurate maintenance of training records and compliance with regulatory requirements. Identify and assess training needs across departments. Prepa

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