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.

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 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.

Qualifications

  • 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.

  • Natural Authority.

  • Having stature.

  • Experience with presentations.

  • Communication skills (verbal and in writing).

  • Fluency in the Dutch and English language.

Whom to contact at Leiden Bio Science Park?

Contacts