Qualified Person: QA Lead & Regulatory Compliance

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

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.