Qualified Person (QP)

HAL Allergy Group; Leiden; On-site; EUR 90,000 - 130,000; Full time

Benefits offered by this job

30 leave days

Pension contribution

Health insurance

Job summary

HAL Allergy seeks a Qualified Person (QP) to own the release of investigational medicinal products in Leiden. You will certify batches, ensure compliance, and act as QA-representative in R&D projects while maintaining quality systems and liaising with authorities.

Ideal candidates have a pharmacist degree, IGZ eligibility, 3+ years as a QP in aseptic manufacturing, and fluency in Dutch and English. The role emphasizes continuous improvement and external audit readiness.

Qualifications

• Academic degree (preferably as a pharmacist).
• Eligible as a Qualified Person by IGZ.
• Min 3 years of experience as a Qualified Person 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.
• Fluency in Dutch and English.

Responsibilities

• Batch certification and release of (investigational) medicinal products in accordance with EU directives.
• Investigate deviations and approve/finalize deviations.
• Approval of Change Controls.
• Regulatory authorities liaison to maintain compliance (IGZ, Farmatec, PEI).
• Participation in R&D projects as QA-representative.
• Approval and execution of internal and supplier audits; audit follow-up.
• Focal Point of Contact for external audits.
• Develop and train QA-Officers; support continuous improvement.
• Maintain Quality Management Systems; Deviations and Product Quality Review.
• Investigation of Product Quality Complaints.
• Quality Agreements with suppliers and subcontractors.

Skills

Audit experience

Fluency in Dutch and English

Critical thinking

Interpersonal and problem solving

Education

Pharmacist degree

Job description

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.

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).
• 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 Allergy.
• Participation in R&D Project teams as QA-representative.
• Approval and execution, including follow-up of internal - and external (supplier) audits.
• Focal Point of Contact for external audits.

Furthermore:

• You 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.
• ideally min 3 years of experience as a Qualified Person 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.
• Fluency in the Dutch and English language.

Who are you?

You are a self starter able to think critically and ready to take charge in high stakes situations. You can make hard choices based on your interpersonal and problem solving skills. You are naturally curious and open to learn. We expect a proactive attitude and a continuous search for opportunities to improve processes and product quality.

• You will be part of a steadily growing and dynamic biopharmaceutical company offering a great environment for self-starters.
• A culture that is characterized by entrepreneurial spirit and a friendly and helpful atmosphere. The patient's well-being is always our top priority. This combination is the basis for an interesting and challenging environment.
• You will be working in our dynamic headquarters in Leiden, where we work on the full product pipeline from development to commercial production.
• Being part of a company that is geared towards helping people live happier and healthier lives.
• A competitive salary that matches your responsibilities and experience.
• 30 leave days.
• Company contribution to a pension package and heath insurance

HAL Allergy, for those who seek for pharmaceutical innovation

HAL Allergy is one of the European top players in the development, production and distribution of allergen immunotherapies for the treatment and prevention of allergic diseases. We focus on the development and manufacturing of modified allergen extracts for the therapeutic and diagnostic purposes of respiratory and food allergies. With all our activities the patient's well-being is always top of mind.