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
- 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 HAL.
- Participation in R&D Projectteams as QA-representative.
- 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 and Product Quality Review.
- Investigation of Product Quality Complaints.
- Installation and maintenance of Quality Agreements with suppliers and subcontractors as part of supplier qualification program.
- Academic degree (preferably as a pharmacist).
- Eligible as a Qualified Person by IGJ.
- Experience (QP: 2yrs +) with aseptical manufacturing.
- Solid knowledge of (bio)pharmaceutical processes and the (bio)pharmaceutical industry (R&D, QC and production).
Personal & Professional Skills
- Experience with the implementation and maintenance of Quality Management Systems.
- Audit experience and interview techniques.
- Fluency in the Dutch and English language.
- Decisiveness, analytical thinking and accuracy.
- Natural Authority.
- Experience with presentations.
- Communication skills (verbal and in writing).