QA/QC Officer

VitalAire Canada Inc.; Schelle; À distance; EUR 45 000 - 70 000; Plein temps

Résumé du poste

Air Liquide Medical Ltd. NV in Schelle, Belgium, is seeking a QA/QC Officer to support the Benelux Pharmaceutical / Quality Department, reporting to the Quality Control Manager.

You will perform batch release, review documentation, and ensure GMP, GDP, and MDR/ISO 13485 compliance across medicinal and non-medicinal products. This role collaborates with Operations, QA, HSE, Maintenance, and external partners, conducts deviations and investigations, and contributes to audits and PQR writing, while

Qualifications

• Strong understanding of GMP, GDP, GLP and ISO 13485/MDR frameworks.
• Experience with batch release and certificate of analysis approvals.
• Familiarity with quality investigations and CAPA processes.

Responsabilités

• Review production and laboratory batch documentation.
• Perform final batch release of non-medicinal products and approve COAs.
• Lead deviations and OOS investigations and report findings to QC manager.
• Coordinate Change Controls and CAPAs related to GMP activities.
• Prepare and update SOPs, PQs, and PQRs; support audits and inspections.

Connaissances

Quality investigations

Batch review

GMP knowledge

Analytical thinking

Communication

Formation

Bachelor's or Master’s degree in Life Sciences/related

Outils

MS Office

Laboratory information systems

Description du poste

## QA/QC OfficerApply: Belgium, Schelle: Full time: Posted Today: R10102321Air Liquide Medical Ltd. NV and Air Liquide Healthcare Netherlands provide healthcare professionals and patients with solutions that contribute to our mission of protecting vulnerable lives. We are constantly inventing and developing solutions for healthcare facilities. In the Hospital Care (Belux) business, our employees serve more than 7,500 hospitals and clinics every day, supplying them with oxygen and other medical gases. In the Homecare business (Belux), our employees take care of the respiratory treatment at home of, among others, more than 40,000 patients.**How will you CONTRIBUTE and GROW?**As QA/QC Officer, you are part of the Benelux Pharmaceutical / Quality Department and you report directly to the Quality Control Manager (Qualified Person). In this role, you work closely with the QC Manager to provide daily operational support for all pharmaceutical and quality tasks related to the production of medicinal and non-medicinal products at our European GMP site in Schelle. As a key quality support, you monitor quality tasks for the entire chain, from starting materials to finished products, while ensuring strict compliance with Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and Medical Device requirements (MDR, ISO 13485). You are also directly responsible for the final batch release of non-medicinal products and raw materials. You collaborate closely with various internal stakeholders (Operations, Production, QA, HSE, Maintenance, Engineering, Sales) as well as external affiliates and suppliers, actively participating in deviations, Out of Specification (OOS) investigations, qualification/validation activities, Product Quality Reviews (PQR), and audit preparations.***Main tasks*** Quality Control, Batch Review & Non-Medicinal Release * Review production and laboratory batch documentation in accordance with internal SOPs, regulatory requirements, and customer quality agreements.* Perform the final batch release of non-medicinal products and approve certificates of analysis (CoA) for sampling at client sites.* Manage the release of raw materials, packaging materials, and intermediate products used in production.* Conduct regular quality tours and monitor compliance with GMP and flow/zoning in both production and lab areas. Deviations, OOS & Quality Investigations * Lead investigations and draft detailed reports for deviations, Out of Specification (OOS) results, customer complaints, and non-conformities, reporting findings directly to the QC Manager.* Handle Change Controls and CAPAs (Corrective and Preventive Actions) related to GMP and quality activities. Validations, Projects & Continuous Improvement * Prepare, execute, and follow up on validation and qualification activities for equipment, analytical instruments, and processes in production and laboratory areas.* Author and update written procedures, manuals, SOPs, and related quality documents.* Write the annual Product Quality Review (PQR) for medicinal products.* Support the preparation and execution of site health authority inspections, customer audits, supplier audits, and internal self-inspections across sites. Training & Compliance * Deliver GMP, GDP, and Pharmacovigilance training to QC operators, production personnel, warehouse staff, and drivers.* Ensure continuous compliance with local and European pharmaceutical regulations, Ph. Eur., and medical device standards.**Are you a MATCH?*****Profile*** Education & Experience * Bachelor’s or Master’s degree in Life Sciences, Bio-engineering, Industrial Pharmacy, Chemistry, or a related scientific discipline.* 0 to 3 years of experience in a Quality Assurance or Quality Control environment (pharmaceutical, biotech, or medical devices). First hands-on experience (including internship or master thesis) in a GMP/GLP environment is highly valued. Technical & Quality Skills * Good theoretical knowledge or practical exposure to pharmaceutical guidelines and quality frameworks: GMP, GDP, GLP, Ph. Eur., and ISO 13485 / MDR.* Strong interest in quality investigations, root-cause analysis (OOS/CAPA), batch record review, and compliance.* Basic understanding or first exposure to equipment/process validation and qualification activities.* Proficiency with IT systems (MS Office, Google Workspace). Personal & Interpersonal Skills * Highly structured, rigorous, and attentive to detail with a strong quality mindset.* Eager to learn, proactive, and open to feedback, with the motivation to grow within a pharmaceutical operational environment.* Excellent communication and interpersonal skills to collaborate smoothly with multidisciplinary teams (Production, Maintenance, HSE, Affiliates).* Pragmatic problem-solver who stays calm, composed, and efficient under pressure or during unexpected situations. Languages * Fluent in Dutch and English (written and spoken).* Knowledge of French is a strong asset (nice to have)