Quality Operations Lead: Investigations & CAPAs

Alfasigma; Pomezia; In loco; EUR 40.000 - 46.000; Tempo pieno

Descrizione del lavoro

Alfasigma in Italy seeks a Quality Operation Specialist reporting to the Quality Operation Coordinator, within a team of 9. You will lead investigations for deviations, complaints and quality events, supervise batch records, logbooks and GMP documents on the shop floor, and help implement CAPAs.

You will coordinate cross-functional teams, support audits and regulatory inspections, monitor CAPA metrics, draft investigation reports, and ensure SOP/GMP compliance while maintaining TrackWise records.

Competenze

• Bachelor’s degree in Pharmaceutical Chemistry and Technology (CTF), Pharmacy, Chemistry, or related field.
• Knowledge of investigation and root cause analysis tools (Fishbone Diagram, 5 Whys, FMEA).
• Strong command of English and Italian; excellent technical writing skills.
• Experience in pharmaceutical manufacturing preferred (3–4 years).
• Familiarity with GMP, SOPs and CAPA processes is advantageous.

Mansioni

• Lead and coordinate investigations for deviations, complaints and quality events with robust root cause analysis and CAPA actions.
• Manage market and customer complaints including impact assessments and recurrence analysis with stakeholders.
• Facilitate cross-functional teams and ensure timely closure of investigations and CAPAs per GMP procedures.
• Monitor metrics, escalate risks, and draft detailed investigation reports with corrective actions and effectiveness checks.
• Oversee production activities to ensure SOP and GMP compliance and support audits/regulatory inspections.
• Contribute to periodic quality reviews and maintain GMP documentation (SOPs, Master Batch Records) in TrackWise.

Conoscenze

Root cause analysis

Investigations

CAPA management

Technical writing

Cross-functional collaboration

English/Italian bilingual

Formazione

Bachelor's degree in Pharmaceutical Chemistry and Technology or related field

Strumenti

TrackWise

Descrizione del lavoro

Alfasigma in Italy seeks a Quality Operation Specialist reporting to the Quality Operation Coordinator, within a team of 9. You will lead investigations for deviations, complaints and quality events, supervise batch records, logbooks and GMP documents on the shop floor, and help implement CAPAs.

You will coordinate cross-functional teams, support audits and regulatory inspections, monitor CAPA metrics, draft investigation reports, and ensure SOP/GMP compliance while maintaining TrackWise records.