For one of our clients, located in Wavre, we are currently looking for a "QA coordinator".
The QA Coordinator is responsible for providing quality assurance support for the quality system requirements for Belgium and Luxembourg associated with: pharmaceutical products, medical devices, combination products and biologic.
This position is responsible for all product, QA process or system in compliance with Corporate, governmental and local regulations and requirements. Areas of support may also include Storage and Distribution, Supplier Controls, Product Quality Complaints, Potential Quality Events/Product Shortage Execution, Product Quality Review, Risk Management, Agency Inspections/Internal Audits, CAPA, and overall Quality Manual requirements.
- Ensures integration and support of quality regulations: drug, biologics, device and/or combination products.
- Work independently, review and authorize to sale final product based on approved processes and European and local regulation.
- Assist in the design of effective quality systems, procedures and/or processes within the commercial QA Western Europe organization that should be suitable for Belgium commercial office.
- Assist in assessing current QA processes and procedures at the Belgium affiliate identifying as applicable improvement opportunities
- Partner, coordinate and support activities related to product actions in the affiliate.
- Support internal and external quality inspections and audits including reporting, response to observations and tracking of action plans.
- Support the Belgium Responsible Person to coordinate and investigate quality events such as deviations, non-conformance's, product quality complaints and corresponding action plans including decisions.
- Represent affiliate QA in regional, global and cross functional teams, projects and programs, as assigned by management.
Do the above responsibilities fit you like a glove?
Download your CV and motivation letter via the "apply now" button and you can expect feedback from us soon.
If something is not entirely clear, you can reach out to us by telephone off course.
- Master degree of pharmacist or master in pharmaceutical sciences, medical doctor or master in medical sciences, veterinary or master in the veterinary sciences, chemist or master in chemistry, biologist or master in biology, biomedical scientist or master in the biomedical sciences.
- 5+ years' experience in quality assurance, quality oversight or relevant experience.
- Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations.
- Strong computer skills and knowledge of standard enterprise QA IT systems.
- Knowledge of QA systems and GxP compliance requirements including regulations and standards affecting device, biologics and pharmaceutical products preferred.
- Strong oral, written communication and presentation skills.
- Proficiency in Dutch/French/English.
- Excellent interpersonal skills.
- RP requested
- A balanced salary package based on your capabilities and experience.
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy Number: 16255