Key Skills

Job Description

Quality Engineer – Investigation Owner Are you an experienced Quality Engineer who enjoys getting to the root of complex quality issues and working closely with manufacturing teams? We are looking for a Quality Engineer / Investigation Owner to take ownership of quality investigations within a pharmaceutical manufacturing environment. You will lead investigations from initiation through completion, identify root causes, coordinate CAPAs and change controls, and help ensure strong GMP compliance across operations. What will you be doing? Lead non-conformance and quality investigations from initiation through closure. Perform root cause analysis and coordinate appropriate corrective and preventive actions (CAPA). Initiate and lead Change Controls (CC) for the Operations unit. Assemble and coordinate cross-functional teams required to investigate and close quality records. Ensure accurate, compliant documentation and timely completion of quality records. Review manufacturing documentation, processes and activities from a Quality perspective. Maintain and update procedures based on regulatory requirements, audits and internal investigations. Identify quality and compliance risks and support formal escalation when necessary. Initiate and support continuous improvement and risk mitigation activities. Perform regular GEMBA walks on the production floor to monitor GMP compliance, identify improvement opportunities and work with Operations on corrective actions. Communicate investigation outcomes, risks and actions clearly to relevant stakeholders. What are we looking for? A relevant HBO degree or equivalent. At least 5 years of relevant experience within the pharmaceutical industry. Hands-on experience as an Investigation Lead, Quality Engineer, QA Specialist or in a similar Quality role. Strong experience with GMP investigations, non-conformances, CAPA, Change Control and root cause analysis. Good understanding of pharmaceutical manufacturing operations and GMP requirements. English at B2 level or higher. Comfortable working with MS Office, data analysis and relevant business/QMS applications. You will be successful in this role if you are: Analytical and able to identify gaps and determine root causes. Proactive and comfortable taking ownership of investigations. Structured and accurate, with a strong quality mindset. Able to remain calm and effective when priorities change or deadlines are tight. Confident working independently while collaborating with cross-functional teams. A clear communicator who can align stakeholders and escalate risks when needed. This is a hands-on Quality position where you will be close to manufacturing and the production floor, rather than working purely on documentation. You will have real ownership of investigations and play an important role in resolving quality issues and improving processes in a regulated pharmaceutical environment.

Core Responsibilities

Lead quality investigations from initiation through closure, determine root causes, and coordinate CAPAs and Operations change controls. Ensure compliant documentation and GMP practices, review manufacturing activities, conduct production-floor GEMBA walks, and communicate risks and improvement actions to stakeholders.

Requirements

Requires a relevant higher professional education (HBO) degree or equivalent and at least five years of relevant pharmaceutical industry experience. Candidates should have hands-on quality investigation experience, strong knowledge of GMP, CAPA, change control and root cause analysis, English proficiency at B2 or higher, and familiarity with MS Office and QMS applications.