Clinical Supply QA Expert - GMP/GDP & Labeling

Sire Search; Breda; On-site; EUR 70,000 - 90,000; Full time

Job summary

Our client in Breda, a life sciences company, seeks a Clinical Supply Chain Quality Assurance Specialist to ensure GMP/GDP compliance across the clinical supply chain and support production-related quality activities.

You will review batch documentation, approve clinical label artwork, and coordinate with manufacturing, packaging, and regulatory teams to ensure timely release and distribution for clinical trials.

Qualifications

• Master’s degree in Life Sciences or related field.
• Several years of experience in Quality Assurance and/or manufacturing within pharma, biotech, or medical devices.
• Hands-on experience with documentation review (e.g., batch records) and deviation/investigation support.

Responsibilities

• Provide quality guidance and oversight for investigational medicinal products to ensure GMP/GDP compliance
• Review batch documentation to support batch certification activities
• Review and approve clinical label artwork and support packaging/labelling quality checks
• Assess and document temperature excursions during transport and at clinical sites/depots
• Support investigation and resolution of quality/compliance issues related to manufacturing, packaging, and distribution
• Review and approve minor deviations in line with internal procedures and regulatory expectations
• Draft, update, and maintain operational SOPs and work instructions
• Review SOPs to ensure alignment with corporate standards, site procedures, and regulatory requirements
• Prepare and contribute to monthly quality metrics and reporting
• Work cross-functionally with stakeholders across supply chain, warehouse/distribution, production, - quality, clinical operations, and regulatory teams
• Perform QA-on-the-floor activities such as pack checks, batch record review, and compliance checks - ---during manufacturing activities

Skills

GMP/GDP

QA oversight

Documentation review

Deviation investigation

Clinical supply chain

Education

Master’s degree in Life Sciences

Job description

Our client in Breda, a life sciences company, seeks a Clinical Supply Chain Quality Assurance Specialist to ensure GMP/GDP compliance across the clinical supply chain and support production-related quality activities.

You will review batch documentation, approve clinical label artwork, and coordinate with manufacturing, packaging, and regulatory teams to ensure timely release and distribution for clinical trials.