QUALITY ENGINEER

Description

Qualifications: Must meet at least one of the following requirements: BACHELOR'S DEGREE in Biology or BACHELOR'S DEGREE in Biotechnology; UNIVERSITY MASTER'S DEGREE in Advanced Chemistry Techniques OR Chemical Quality Analysis and Control. Professional experience in the position: 36 months. MICROSOFT OFFICE and SAP. Languages: ENGLISH. Contract type: Permanent. Working hours: 09\-18H. Mandatory requirement: Disability Review and approval of manufacturing procedures, general procedures, and work instructions. Change Management: Assess the impact of proposed changes. Approve action plans and supervise their correct implementation. Review qualification of facilities, equipment, and utilities, including qualification strategy, execution, and management of any deviations identified. Execute and/or approve Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT). Review process validations, including validation strategy, execution, and management of any deviations identified. Define validation strategies for changes. Review validation strategies and associated documentation (protocols and reports). Conduct, review, and approve risk assessments carried out by external manufacturers (OEM). Deliver training on validation and risk management to OEM personnel, ensuring the organization possesses the necessary competencies for proper implementation and applies recognized methodologies. Participate in internal and external audits as required. Manage Non-Conformities and Corrective and Preventive Actions (CAPA) * 36 months of experience. QUALITY ENGINEER * BACHELOR'S DEGREE * English (Advanced spoken, Advanced written) * Permanent employment contract * Full-time schedule * Gross monthly salary: 3285