Quality Operations Specialist - CAPA & Investigations

Alfasigma; Pomezia; In loco; EUR 45.000 - 65.000; Tempo pieno

Descrizione del lavoro

Alfasigma is seeking a Quality Operation Specialist who will report to the Quality Operation Coordinator and join a nine-member team. The role focuses on investigations related to deviations, complaints, and other quality events, coordinating CAPAs, and ensuring GMP compliance on the shop floor.

You will draft detailed reports, analyze product impact, and support regulatory inspections while maintaining TrackWise quality records and SOPs. Strong English and Italian writing skills are essential.

Competenze

• Bachelor's degree in pharmaceutical sciences or related field.
• 3–4 years in a pharmaceutical manufacturing environment.
• Knowledge of investigation tools (Fishbone, 5 Whys, FMEA) preferred.

Mansioni

• Lead investigations for deviations, complaints and quality events with robust root-cause analysis.
• Coordinate CAPAs and ensure timely closure per GMP procedures.
• Manage market and customer complaints and perform product impact assessments.
• Draft reports and verify effectiveness of corrective actions.
• Oversee production activities to ensure SOP and GMP compliance.
• Support audits and regulatory inspections.
• Maintain quality records in the QMS TrackWise.

Conoscenze

Root Cause Analysis

CAPA Management

Quality Investigations

GMP Documentation

Formazione

Bachelor's degree in Pharmaceutical Chemistry and Technology

Strumenti

TrackWise

Descrizione del lavoro

Alfasigma is seeking a Quality Operation Specialist who will report to the Quality Operation Coordinator and join a nine-member team. The role focuses on investigations related to deviations, complaints, and other quality events, coordinating CAPAs, and ensuring GMP compliance on the shop floor.

You will draft detailed reports, analyze product impact, and support regulatory inspections while maintaining TrackWise quality records and SOPs. Strong English and Italian writing skills are essential.