AI-Savvy Qualified Person for GMP Compliance, Flexible Hours

Ardena Careers; Oost-Vlaanderen; On-site; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Meal vouchers

Group hospitalization insurance

Flexible working hours

32 holidays

Job summary

Ardena Gent is seeking a Qualified Person to certify batches of investigation medicinal products (IMPs) in compliance with applicable legislation. You will oversee documentation, audits, and regulatory communications to maintain GMP standards.

A Master of Science in Pharmaceutical Sciences and 5 years QP experience are required. The role involves collaboration across teams in a dynamic, international environment, with a focus on quality and regulatory excellence within the Drug Product

Qualifications

• Master of Science in Pharmaceutical Sciences is required.
• Registered or qualified to apply for Qualified Person (QP) by FAMHP.
• Knowledge of GMP quality system and regulatory requirements (Eurdralex, ICH).
• 5 years of QP experience in pharma.

Responsibilities

• Review documents for completeness and compliance.
• Ensure the Product Specification File (PSF) is up to date.
• Evaluate deviations and out-of-specification results related to IMP subject to QP certification.
• Approve internal and contractor audit plans and attend audits.
• Provide QA support across multiple projects and communicate with authorities.
• Keep up to date with GMP legislation and approve Technical Quality Agreements.
• Draft procedure documents related to batch certification.
• Act as a reference point in GMP manufacturing meetings.

Skills

Strong communication

Team player

Solution driven

Adaptable / change oriented

AI savviness

MS Office

Education

Master of Science in Pharmaceutical Sciences

Tools

MS Office

Job description

Ardena Gent is seeking a Qualified Person to certify batches of investigation medicinal products (IMPs) in compliance with applicable legislation. You will oversee documentation, audits, and regulatory communications to maintain GMP standards.

A Master of Science in Pharmaceutical Sciences and 5 years QP experience are required. The role involves collaboration across teams in a dynamic, international environment, with a focus on quality and regulatory excellence within the Drug Product