Quality Assurance Specialist - GMP

The Compliance Specialist is responsible to support Manufacturing by investigating, authoring and managing non-conformance reports (NCRs) for production and environmental monitoring (EM) events. Assign corrective and preventative actions (CAPAs) and effectiveness checks (ECs) to address issues identified throughout production. Work with cross-functional teams, including production, quality control, quality assurance and facilities , to ensure efficient problem-solving and resolution of non-conformance issues. Communicate findings, actions, and improvements to relevant stakeholders and management. Key Responsibilities: Non-Conformance Report (Client) Management: - Investigate both significant and non-significant NCRs for production and EM events. - Analyze data and Identify the root causes to ensure a thorough investigation and identification of underlying issues. - Write and maintain comprehensive Client reports, including all necessary details such as cause, impact, and actions taken. Corrective and Preventative

Created: 2025-03-03