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.

Further

  • 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.

Requirements

  • 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).

Biotech Training Facility: unique professional GMP and biosafety courses in a state-of-the-art environment.

BTF