description du poste

QA CSQ Associate – Clinical Supply Quality

About the Role

We are looking for a QA CSQ Associate to join the Clinical Supply Quality (CSQ) team, supporting the certification and release of Investigational Medicinal Products (IMPs) used in global clinical trials. Acting as a QP Delegate, you will ensure clinical trial materials meet GMP/GDP requirements and regulatory standards, safeguarding patient safety and product quality.

You will work closely with Clinical Supply Chain, Quality, and Regulatory teams to ensure the timely and compliant release of clinical trial drug products.

Key Responsibilities

• Support QP certification and release of IMPs for global clinical trials.
• Provide quality oversight across clinical supply chains for innovative pharmaceutical products.
• Review batch documentation, analytical results, and GMP documentation to support product release.
• Ensure compliance with GMP, GDP, and clinical trial regulations.
• Support deviation, complaint, and CAPA investigations to maintain product quality and supply continuity.
• Participate in internal and external audits and regulatory inspections.
• Act as Quality point of contact for assigned compounds within the clinical supply network.
• Contribute to continuous improvement initiatives within QA and cross-functional teams.

Essential Requirements

• Certified Industrial Pharmacist qualification.
• Minimum 5 years' experience in the pharmaceutical industry in a GMP-regulated environment.
• Experience in batch record review, product release, or QA oversight.
• Knowledge of GMP, GDP, and pharmaceutical regulatory frameworks (e.g. EU GMP, ICH).
• Fluent Dutch and English (written and spoken).

Preferred Experience

• Experience with Investigational Medicinal Products (IMPs) or clinical trial supply chains.
• Experience supporting QP certification or acting as a QP delegate.
• Familiarity with quality systems such as SAP, TrackWise, RIMS/TruVAULT, COMET, Summit, or eLIMS.
• Experience supporting regulatory inspections or quality audits.

Practicalities

• Location: Beerse, Belgium
• Work model: Onsite role

Interested? Apply now or send CV to l.ormrod@panda-int.com