Senior Qualified Person - GMP Compliance & Certification

Ardena; Oost-Vlaanderen; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Meal vouchers

Group/hospitalization insurance

Learning environment

International company

Dynamic work environment

Caring culture

32 holidays

Flexible working hours

Job summary

Ardena Gent guides a worldwide portfolio of customers through formulation and analytical development, regulatory filings, and GMP-compliant manufacturing of early-phase materials. The role is to act as the Qualified Person and ensure batch certification in accordance with applicable legislation.

The successful candidate will review documentation, maintain PSF, evaluate deviations, participate in audits, and communicate with authorities, while staying up-to-date with GMP changes and QP

Qualifications

• Master of Science in Pharmaceutical Sciences.
• Registered or eligible to apply for QP with FAMHP.
• Knowledge of GMP and regulatory requirements (Eurdralex, ICH).
• Minimum 5 years QP experience in pharma.
• Strong problem solving and communication skills.

Responsibilities

• Certify IMP batches per legislation.
• Review documents for completeness and compliance.
• Maintain Product Specification File (PSF).
• Evaluate deviations and OOS results.
• Approve internal and contractor audit plans and reports.
• Participate in internal audits and meetings with Contract Giver.
• Approve Technical Quality Agreement.
• Draft and approve procedures affecting batch certification.
• Communicate with authorities during inspections.
• Stay updated on GMP legislation.

Skills

QP experience

GMP knowledge

Regulatory knowledge

Communication skills

Team player

Education

Master of Science in Pharmaceutical Sciences

Tools

MS Office

Job description

Ardena Gent guides a worldwide portfolio of customers through formulation and analytical development, regulatory filings, and GMP-compliant manufacturing of early-phase materials. The role is to act as the Qualified Person and ensure batch certification in accordance with applicable legislation.

The successful candidate will review documentation, maintain PSF, evaluate deviations, participate in audits, and communicate with authorities, while staying up-to-date with GMP changes and QP