Jobid=98500f022682 (0.0737)
Qualified Person
As a Qualified Person (QP) at HAL Allergy, you hold legal responsibility for certifying batches of medicinal products before they are used in clinical trials or released to the market. But your role goes beyond technical expertise in manufacturing — you understand the broader factors that impact medicine safety and supply reliability.
We’re looking for a Qualified Person (QP) who takes ownership of the release of our (investigational) medicinal products. In this key position, you ensure that no product is supplied or sold without proper certification, safeguarding both quality and patient safety.
Your tasks
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).
Investigate in close collaboration with the Deviations Specialist and approve/finalize the deviation(s).
Approval of Change Controls.
Focal point of contact with regulatory authorities (IGZ, Farmatec, PEI) to maintain the compliance status of HAL.
Participation in R&D Project teams as QA-representative.
Approval and execution, including follow-up of internal – and external (supplier) audits.
To support quality-based decision processes.
Focal Point of Contact for external audits.
Furthermore:
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.
You have
Academic degree (preferably as a pharmacist).
Eligible as a Qualified Person by IGZ.
Experience (QP: 2yrs +) with aseptical manufacturing.
Solid knowledge of (bio-)pharmaceutical processes and – industry (R&D, QC and production).
Experience with the implementation and maintenance of Quality Management Systems.
Audit experience and interview techniques.
Fluent in the Dutch and English language.
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