Key Skills

Job Description

Alcami is a leading global contract development and manufacturing organization (CDMO) providing fully integrated solutions for the pharmaceutical and biotechnology industries. Following the acquisition of Tjoapack, we have strengthened our global capabilities in pharmaceutical packaging, supply chain services and manufacturing support. At our site in Etten-Leur, we specialize in the packaging of life-saving medicines, ensuring patients around the world receive their medication safely, reliably and on time. Every day, our people make a direct impact on global healthcare. Why This Role Matters As QA Specialist, you will play a key role in safeguarding product quality, regulatory compliance and the effectiveness of our Quality Management System. Your work will provide clear, evidence-based insight into product and process performance and help ensure that significant quality issues are investigated thoroughly and resolved effectively. You will take ownership of Product Quality Reviews (PQRs), major deviation investigations, KPI reporting, incoming and supplier complaints, and Quality Technical Agreements (QTAs). In addition to supporting the Etten-Leur site, you may contribute to the preparation of global PQRs and QTAs, collaborating with colleagues and stakeholders across the wider organization. You will also support and lead QA projects and continuous improvement initiatives as part of your role. If you are an analytical and proactive QA professional who enjoys technical writing, structured investigations, stakeholder coordination and translating quality data into meaningful conclusions and actions, this role offers the opportunity to make a direct impact on patients and continuous quality improvement. What You'll Do In this role, you will manage a varied portfolio of quality activities, with a strong focus on PQRs, investigations, complaints and quality agreements. Your responsibilities include: Prepare, coordinate and finalize site-level Product Quality Reviews (PQRs), ensuring that relevant data is assessed, trends are identified and conclusions and follow-up actions are clearly documented. Support the preparation and coordination of global PQRs, where required, by aligning input from multiple sites and functions and contributing to consistent, high-quality reporting. Lead the investigation of major deviations, using structured root cause analysis and ensuring that investigations, impact assessments and CAPAs are scientifically justified, timely and compliant with GMP requirements. Manage the end-to-end complaint process (supplier and client complaint), including intake, prioritization, communication, timely closure, trending and follow-up of actions. Investigate incoming customer complaints, coordinate input from relevant departments and ensure that root cause, product impact and required corrective or preventive actions are adequately assessed and documented. Draft, review, negotiate and maintain Quality Technical Agreements (QTAs) with customers, ensuring that quality responsibilities and expectations are clearly defined. Support the drafting and maintenance of global QTAs, where required, and collaborate with global and local stakeholders to achieve alignment across sites and functions Provide support with supplier management related tasks. Provide practical QA guidance and support for general quality-related questions, documentation and tasks, including activities within the Quality Management System. Collaborate with cross-functional teams and contribute to continuous improvement by identifying trends, escalating risks and supporting the implementation of sustainable quality improvements. What You'll Bring We're looking for an analytical, quality-driven and proactive QA professional who combines strong technical writing and investigation skills with effective stakeholder management. You bring: A bachelor’s degree in a pharmaceutical, life sciences, technical or other relevant scientific field. Relevant experience in Quality Assurance within a GMP-regulated pharmaceutical, biotechnology or medical products environment. Experience in preparing or reviewing Product Quality Reviews/ Annual Product Reviews or comparable periodic quality reports, with the ability to interpret data, identify trends and formulate clear conclusions. Strong investigation and root cause analysis skills, with experience in deviations, complaints, impact assessments and CAPA management. Knowledge of GMP, GDP and Quality Management System principles; experience with Quality Technical Agreements is an advantage. Excellent written and verbal communication skills, with the ability to write clear, accurate and audit-ready quality documentation and to work effectively with local and global stakeholders. A structured, detail-oriented and pragmatic approach, the ability to manage multiple priorities independently, and fluency in both Dutch and English. What We Offer At Alcami, you’ll join an international organization where quality, collaboration and continuous improvement go hand in hand. We believe our people make the difference and support their development. You can expect: A challenging and meaningful role in an international pharmaceutical organization. The opportunity to take ownership of and further develop key Quality Assurance activities, including Product Quality Reviews, major deviation investigations, complaint management and Quality Technical Agreements. A tailored development plan and opportunities for training and continuous learning. Collaboration with experienced colleagues in a diverse and professional team. 30 vacation days and an attractive pension scheme. Annual salary increases based on performance. A competitive salary and attractive secondary employment conditions. Why Alcami? At Alcami, every role contributes to one shared purpose: improving patients’ lives. Your expertise will help ensure that the medicines packaged at our Etten-Leur site meet the highest quality standards and reach patients safely and reliably. If you are ready to make an impact, strengthen quality processes and contribute to work that matters, we would love to hear from you. Interested? Please submit your CV and motivation letter in English via the Apply button. Address your application to Samira Houdane, Corporate Recruiter.

Core Responsibilities

Prepare and coordinate site and global Product Quality Reviews, lead major deviation investigations, and manage supplier and customer complaints, including root cause analysis, impact assessments, and corrective actions. Draft and maintain Quality Technical Agreements, support supplier management and Quality Management System activities, and contribute to cross-functional quality improvements.

Requirements

A bachelor’s degree in a relevant scientific or technical field and relevant Quality Assurance experience in a GMP-regulated pharmaceutical, biotechnology, or medical products environment are required. Candidates should have experience with periodic quality reports, investigations, complaints, and CAPA, knowledge of GMP, GDP, and Quality Management Systems, strong technical writing and stakeholder skills, and fluency in Dutch and English.

Benefits

• 30 Vacation Days
• Attractive Pension Scheme
• Annual Performance-Based Salary Increases
• Training and Continuous Learning
• Tailored Development Plan