Qualified Person at HAL Allergy
As a Qualified Person you are responsible for the release of (investigational) Medicinal Products. You support quality-based decision processes and are a focal point of contact for external audits.
Tasks and Responsibilities
As a QP you are responsible for batch certification and release of (investigational) medicinal products in accordance with the Marketing Authorization/IMPD and with current EU-Directives. You are a focal point of contact with regulatory authorities (IGJ, Farmatec, PEI) to maintain the compliance status of HAL Allergy.
For internal and external (supplier) audits you take on the approval, execution and follow-up. Within the cycles of Deviations and Change Controls, investigation and approval is part of your responsibilities.
With your knowledge and expertise you develop and train QA-Officers and actively support a climate for continuous improvement. You play an important role in the maintenance of the Quality Management Systems, the investigation of Product Quality Complaints and installation and maintenance of Quality Agreements with suppliers and subcontractors.
You have an academic degree, preferably as a pharmacist, with at least 2 years of experience as QP. You have experience with aseptic manufacturing and have solid knowledge of (bio)pharmaceutical processes and the (bio)pharmaceutical industry. You are already eligible as a Qualified Person by IGJ.