Sr Associate, QA Compliance
Pubblicato il 17-08-2026 - Alfasigma in Pomezia
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 (eQMS). 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
- Manage the training process within the eQMS, ensuring accurate maintenance of training records and compliance with regulatory requirements.
- Identify and assess training needs across departments.
- Prepare, deliver, and monitor training materials and programs, including GMP and compliance-related topics.
- Evaluate the effectiveness of training programs and implement improvements where necessary.
- Act as a GMP subject matter expert and support the continuous improvement of training effectiveness.
- Mentor and support colleagues, fostering a strong quality and compliance culture.
- Oversee the CAPA (Corrective and Preventive Actions) process, including tracking, follow‑up, effectiveness checks, and timely closure.
- Participate in or lead CAPA‑related projects, ensuring compliance, quality, and adherence to deadlines.
- Compile, analyze, and report performance metrics related to CAPAs, Change Controls, and other Quality System activities.
- Support continuous improvement initiatives within the Quality Management System.
- Manage and maintain document control processes within the eQMS.
- Support the issuance, revision, and periodic review of Standard Operating Procedures (SOPs), ensuring alignment with regulatory and corporate standards.
- Ensure