Qualified Person HALIX at HAL Allergy
As a QP you are responsible for the release of (investigational) Medicinal Products. You support quality-based decision processes and are a focal Point of contact for client audits.
Batch certification and release of (investigational) medicinal products in accordance with the Marketing Authorisation/IMPD and in accordance with current EU-Directives (specifically Article1 from Directive 23001/83/EC and Directive 2003/94/EC).
Investigation and approval of Deviations.
Approval of Change Controls.
Focal point of contact with regulatory authorities (IGJ, Farmatec, PEI) to maintain the compliance status of HALIX.
Approval and execution, including follow-up of internal – and external (supplier) audits.
To develop and train QA-Officers and actively support a climate for continuous improvement.
Maintenance of the Quality Management Systems: Auditing, Deviations, Change controls & CAPA’s.
Investigation of Product Quality Complaints.
Installation and maintenance of Quality Agreements with suppliers and subcontractors.
Academic degree (preferably as a pharmacist).
Eligible as a Qualified Person by IGJ.
Experience (QP: 2yrs +) with aseptic manufacturing.
Solid knowledge of (bio-)pharmaceutical processes and industry (R&D, QC and production).
Proven CMC Experience
Personal & Professional Skills
Experience with the implementation and maintenance of Quality Management Systems.
Audit experience and interview techniques.
Decisiveness, analytical thinking and accuracy.
Experience with presentations.
Communication skills (verbal and in writing).
Fluency in the Dutch and English language.