QP – Clinical Manufacturing & QA (Hybrid)

SQUIPP; Ottignies; Hybrid; EUR 110,000 - 140,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

SQUIPP is seeking a Qualified Person (QP) to support clinical trial material release, GMP compliance and pharmaceutical quality operations near Ottignies, Belgium. You will work with R&D, QA, Regulatory Affairs and external partners to ensure compliant product release across markets.

The role offers hybrid working and exposure to international regulatory requirements, with potential final product release responsibilities for China for qualifying candidates.

Qualifications

• Fluent written and spoken English.
• Strong knowledge of EU GMP requirements and pharmaceutical quality systems.

Responsibilities

• Perform delegated QP activities, including batch release and certification of clinical trial materials.
• Review compliance with EU and Belgian GMP requirements, Product Specification Files and approved CMC information.
• Support the certification of materials received at the EU distribution hub.
• Assess and approve retest date extensions and study or country additions.
• Review and approve release documentation, including QP certificates and declarations.
• Support EU GMP equivalency assessments and certification documentation for biological APIs.
• Provide QP oversight of activities performed by manufacturing and packaging partners.
• Assess, investigate and approve deviations and change controls.
• Ensure CAPAs are implemented and verified for effectiveness.
• Review quality performance indicators and identify opportunities for improvement.

Skills

English language proficiency

Education

Master's degree in Pharmacy

Job description

SQUIPP is seeking a Qualified Person (QP) to support clinical trial material release, GMP compliance and pharmaceutical quality operations near Ottignies, Belgium. You will work with R&D, QA, Regulatory Affairs and external partners to ensure compliant product release across markets.

The role offers hybrid working and exposure to international regulatory requirements, with potential final product release responsibilities for China for qualifying candidates.