The opportunity Our client are looking for a hands-on QA/QC Specialist to join a growing pharmaceutical site. This is a unique opportunity to step into a foundational role—you will be the first hire in a new QA/QC team, with clear plans for expansion. This position sits at the intersection of quality and operations. You will work both strategically and operationally – ensuring compliance while being present on the floor when it matters. Your responsibilities You will play a key role in maintaining and developing the Quality Management System while supporting daily operations: Maintain and continuously improve the Quality Management System (QMS) in line with GMP and GDP Perform in-process quality checks (IPQC) and checks upon stock arrival Manage deviations, CAPAs, change controls, and specifications Prepare and maintain SOPs, master documents, and quality records Support batch record (BPR) creation, BOM approvals, and packing activities Conduct GDP inspections and audits of third parties (suppliers, transporters, CMOs) Support and participate in internal and external audits and inspections Investigate and follow up on complaints, temperature excursions, and deviations Ensure training compliance for personnel Oversee validation of systems and equipment Ensure proper storage conditions and temperature monitoring Coordinate product recalls where required Collaborate closely with operations, logistics, QA teams, and external partners This is a role where you are expected to both understand the system (helicopter view) and actively engage in execution (floor level) Your profile We are open to candidates from both QA and manufacturing backgrounds, as long as you bring strong quality awareness. Requirements: Degree in a relevant field (pharmaceutical, life sciences, or similar) 2–5 years of experience within GMP and/or GDP environments Experience of pharmaceutical manufacturing or QA/QC Solid understanding of quality processes and compliance frameworks Strong English skills; Dutch is an advantage but not required Our client are specifically looking for someone who: Understands processes end-to-end, not just isolated tasks Is comfortable working under pressure and with strict deadlines Takes ownership and responsibility for quality decisions Brings business understanding, not just compliance mindset Has the energy to challenge and add dynamism to a structured QA environment Is proactive, solution-oriented, and not afraid to step onto the floor Why this role Be part of building a new QA/QC function from the ground up Work in a role with real impact on patient safety and product quality Combine operational involvement with strategic quality work Join a company operating in a niche where QA/QC expertise is becoming increasingly rare This is an opportunity to combine regulatory expertise, system ownership, and business interaction in a role with high visibility and impact.
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