Qualified Person HALIX at HAL Allergy

Job purpose

Responsibility for the release of (investigational) Medicinal Products.

To support quality-based decision processes.

Focal Point of Contact for client audits.

Responsibilities Qualified Person

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 2001/83/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

Participation in R&D Projectteams as QA-representative.

Approval and execution, including follow-up of internal – and external (supplier) audits.

Further

  • To develop and train QA-Officers and actively support a climate for continuous improvement

  • Maintenance of the Quality Management Systems: Auditing, Deviations,  Change controls & CAPAS.

  • Investigation of Product Quality Complaints.

  • Installation and maintenance of Quality Agreements with suppliers and subcontractors as part of supplier qualification program.

Qualifications

  • 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 – 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.

  • Fluency in the Dutch and English language.
  • Decisiveness, analytical thinking and accuracy.
  • Natural authority.

  • Experience with presentations.

  • Having stature.

  • Communication skills (verbal and in writing).

About HALIX

Founded in 2012 as a corporate venture and spin-off of HAL Allergy, HALIX is a contract development and manufacturing organization (CDMO), based in Leiden, the Netherlands. The company is licensed for the contract manufacturing of clinical and commercial medicines according to GMP standards. HALIX leverages advanced biopharmaceutical technologies and provides the full portfolio of pharmaceutical documentation of GMP production processes, as well as production of units which are required for clinical approval. HALIX, as an end-to-end service provider, will serve its customers the full range from the first development steps to start of commercial production after successful registration of products. More information is available on: www.halix.nl

Find out more about drug development at Leiden Bio Science Park.

R&D