Open to opportunities

Antonio Marena

@antoniomarena

Message

I strengthen GMP quality systems through CAPA, cleaning validation, audits, and sterile manufacturing risk management.

Italy

Message

What I'm looking for

I'm looking to contribute my GMP quality, validation, audit, CAPA, and risk-management experience in a regulated pharmaceutical manufacturing environment focused on compliance and continuous improvement.

I've strengthened GMP quality systems at ReiThera, Esseti Farmaceutici, Recipharm, and Merck, managing CAPAs, internal audits, validation activities, and quality KPIs in regulated sterile manufacturing environments. At Esseti Farmaceutici, I contributed to an AIFA inspection with no significant observations across cleaning validation, risk assessment management, and microbiological monitoring.

I develop cleaning validation and Media Fill protocols, apply ICH Q9 and ICH Q3D risk assessments, and support compliant, evidence-based quality operations. I also create and teach online GMP and Quality Risk Management courses.

Experience

Work history, roles, and key accomplishments

Current

Quality Assurance Specialist

Current

ReiThera

Jan 2024 - Present (2 years 7 months)

Managed the full CAPA lifecycle and supported Aseptic Processing Simulation compliance. Conducted internal audits and performed risk assessments to strengthen GMP compliance.

CAPA Management Internal Audit Risk Assessment GMP Compliance Media Fill Maximo Adiuto