Hugo Dell'Aquila

CONTEXT

As part of this assignment, I had the opportunity to join the QA IT department, which was being created upon my arrival at the Riom site. This allowed me to participate in implementing actions to establish the regulatory framework for this new process on a complex site, through various projects concerning packaging, storage infrastructure, access control management, the laboratory, and production.

ASSIGNMENT DETAILS

- Training

> Train personnel on Good Manufacturing Practices (GMP) and the System Development Life Cycle (SDLC) to ensure a thorough understanding of regulatory requirements and quality standards.

- VSI

> Ensure the compliance of computerized system qualification/validation documents according to the (V-Cycle) and the continued validated state of these systems:

Review and approval of documents (User Requirement Specifications, GxP Assessment Validation Plan, Functional Specifications, Risk Analysis, trace matrix, IQ/OQ protocols and associated reports, non-conformity forms, validation report)

- Quality

> Review of routine documentation: re-validation / periodic reviews

> Propose and monitor corrective and/or preventive actions - Organize and participate in project follow-up meetings

Project Types:

- Equipment decommissioning

- Server and client PC migration

- EMS / Vision system upgrade

- Production line setup

- Adding equipment to lines (HMI, cartoner, labeller, checkweigher...)

CONTEXT

During this assignment, I had the opportunity to develop my skills within the Quality Assurance department, as part of an ongoing remediation plan at the site, overseen by the Global team.

ASSIGNMENT DETAILS

- New CAPAs

> Opening and monitoring CAPAs, ensuring an effective response to non-conformities and the implementation of appropriate corrective measures.

- Old CAPAs

> Remediation of CAPAs that exceeded their closing deadline and were no longer managed in accordance with the global's current procedures.

- Training

> Training personnel on CAPA management, reinforcing the quality culture within the teams and ensuring everyone understands the importance of this process for continuous improvement.

- Continuous Improvement

> Implementation of continuous improvement initiatives, contributing to the optimization of processes such as packaging and warehousing.

CONTEXT

During this assignment, I had the opportunity to develop my skills within the Quality Assurance department, as part of an ongoing remediation plan at the site, overseen by the Global team.

ASSIGNMENT DETAILS

- Handling Customer Complaints

> Drafting of HHEDs and HHEs, which aim to determine the probability of a product's use that could cause harm to the patient or user, as well as the severity of the expected harm across various patient or user populations.

> Updating risk analyses: In-depth analysis of complaints and occurrence calculations to identify and mitigate risks.

- Quality Management - Initiation and monitoring of Quality Holds and batch recalls: Coordination of necessary actions to ensure the quality of products and raw materials.

> Trend analysis related to customer complaints

> Participation in presentations for the weekly review of HHEDs and HHEs.

> Participation in audits conducted by TÜV and TGA on-site.

- Procedures and Training

> Drafting and implementation of the CAPA procedure: Updating procedures for managing corrective and preventive actions.

> Training of key personnel and secondary stakeholders: Transfer of knowledge and skills to teams to ensure effective implementation of processes.

- Continuous Improvement

> Remediation of open CAPAs

> Initiation and processing of new CAPAs

> Initiation of controlled changes: Management of modifications according to established procedures to ensure product conformity and quality.

> Review and transmission of KPIs: Analysis of key performance indicators to ensure regular monitoring and continuous improvement of processes.