Quality Investigations Lead: CAPA & Compliance Expert

Summary

Amneal is seeking an NOI Investigations Specialist to manage in-depth investigations into quality events that could affect product release and regulatory commitments. You will gather data, perform root-cause analyses, and develop CAPAs to prevent recurrence, communicating findings with scientific rationale to auditors and regulators.The role requires strong interviewing, analytical skills, and experience in GMP/FDA environments, aiming to safeguard patient safety, product quality, and#J-18808-Ljbffr

Job Description

Amneal is seeking an NOI Investigations Specialist to manage in-depth investigations into quality events that could affect product release and regulatory commitments. You will gather data, perform root-cause analyses, and develop CAPAs to prevent recurrence, communicating findings with scientific rationale to auditors and regulators.The role requires strong interviewing, analytical skills, and experience in GMP/FDA environments, aiming to safeguard patient safety, product quality, and#J-18808-Ljbffr