| Location | Leiden, Netherlands |
|---|---|
| Business Sector | Pharmaceutical |
| Contact email | |
| Job ref | 26445 |
| Published | about 6 hours ago |
Qualified Person (QP)
Leiden, Netherlands – Full-time (40 hrs/week)
In this role, you hold legal responsibility for the certification and release of medicinal products for clinical trials and commercial distribution. You act as a key decision-maker within Quality, working closely with regulatory authorities, manufacturing, R&D, and suppliers to ensure compliance with EU GMP regulations and reliable medicine supply.
Academic degree in a scientific discipline (preferably Pharmacy)
Eligibility as a Qualified Person recognized by IGZ
Minimum 2+ years of experience acting as a Qualified Person
Strong expertise in aseptic manufacturing environments
Hands-on experience with batch certification and product release
In-depth knowledge of EU GMP regulations, bio/pharmaceutical processes, and quality systems
Experience within a biopharmaceutical or biotechnology environment
Advanced knowledge of Quality Management Systems (QMS) including deviations, change control, and PQR
Experience conducting and hosting internal, external, and supplier audits
Familiarity with regulatory interactions (e.g., IGZ, Farmatec, PEI)
Strong communication, decision-making, and leadership skills
Fluency in both Dutch and English
Start Date: To be agreed
Contract Duration: Permanent
Location: Leiden, Netherlands
Additional: Competitive salary, 13th month, 30 leave days, pension and health insurance contribution
Interviews and offers can move quickly. Send your CV to Ana Jiménez at a.jimenez@panda-int.com today to secure your spot in the process.