Lead Qualified Person: Batch Release & QA Leadership

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

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.