Key Skills

Job Description

Company: A leading organization in the pharmaceutical manufacturing sector, committed to maintaining the highest standards of quality and compliance. The company values innovation, teamwork, and a proactive approach to continuous improvement. Job Description: We are seeking a dedicated Quality Investigation Specialist to oversee and manage quality investigations related to manufacturing processes, products, and systems. This role requires a detail-oriented professional capable of identifying root causes of issues, driving corrective actions, and ensuring adherence to internal and regulatory standards. Responsibilities: Lead and execute quality investigations, including non-conformance records, CAPAs, and change controls. Review process and activity documentation for compliance and accuracy. Maintain and update procedures based on new regulations, investigations, and audits. Ensure all quality records are completed accurately and on time. Support risk mitigation initiatives and continuous quality improvement projects. Escalate risks related to safety, quality, or regulatory issues as needed. Perform regular GEMBA walks to observe GMP compliance on the production floor, identify areas for improvement, and work with teams to implement solutions. Assemble and lead the team required for quality documentation and investigations. Communicate findings effectively to relevant stakeholders. Requirements: Relevant HBO degree with at least 5 years of experience in investigations, quality engineering, or similar roles within the pharmaceutical industry. Proficient in English (B2 level). Intermediate knowledge of MS Office, routine data analysis, and specialist business applications. Strong analytical and problem-solving skills, with the ability to work independently and in a team. Positive, proactive, organized, and able to handle changing priorities. Stress-resistant with a high attention to detail and quality. Accountable and capable of working calmly under pressure. Able to prioritize tasks effectively to meet deadlines and ensure quality. Other Information: If you are interested and want to apply, please submit your application via the apply button below and contact me.

Core Responsibilities

Lead quality investigations involving manufacturing processes, products, non-conformances, CAPAs, and change controls, identifying root causes and driving corrective actions. Maintain compliant quality documentation and procedures, conduct production-floor GEMBA walks, support risk mitigation and continuous improvement, and communicate findings to stakeholders.

Requirements

Requires a relevant higher professional education (HBO) degree and at least five years of experience in investigations, quality engineering, or a similar pharmaceutical-industry role. Candidates should have B2-level English, intermediate MS Office and data-analysis skills, and strong analytical, organizational, communication, and prioritization abilities.