Qualified Person

Qabird; Leiden; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

13th month salary

30 leave days

Pension contribution

Health insurance

Job summary

HAL Allergy in Leiden is seeking a Qualified Person (QP) to take ownership of the release of our investigational medicinal products. You will ensure that no product is supplied or sold without proper certification, safeguarding quality and patient safety.

You will certify batches, address deviations, approve changes, and liaise with regulatory authorities to maintain HAL's compliance standing, while supporting audits and QA activities across the R&D and production spectrum.

Qualifications

• Academic degree; Pharmacist preferred.
• Eligible as a Qualified Person by IGZ.
• At least 2 years of experience in aseptic manufacturing.
• Solid knowledge of (bio-)pharmaceutical processes in R&D, QC and production.
• Experience with Quality Management Systems.
• Audit experience and interview techniques.
• Fluent in Dutch and English.

Responsibilities

• Batch certification and release of investigational medicinal products per MA/IMPD and EU directives.
• Investigate deviations and approve/finalize deviations in collaboration with QA team.
• Approve change controls and manage internal and supplier audits.
• Act as QA representative in R&D project teams and audits with regulators.
• Support quality-based decision processes and maintain supplier quality agreements.

Education

Pharmacist degree

Job description

General information

Leiden | 40 hrs.

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.

Who are we looking for?

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.

Our offer

• 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 project 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.
• A 13th month salary
• 30 leave days.
• Company contribution to a pension package and health insurance.