Senior QA – Clinical Supply Chain & Compliance

Panda International

Breda

On-site

EUR 62,000 - 65,000

Full time

14 days+

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Job summary

Panda International in the Netherlands is seeking a Senior Associate QA for clinical supply chain to provide QA oversight on the supply chain of clinical trial products and support the clinical production area. You will work with Global Clinical Supply Chain, Warehouse/Distribution, Production, Site Quality, Clinical Research Management and Regulatory Affairs.

Key duties include batch review for QP certification, approval of clinical label artwork, assessment of temperature excursions, and

Qualifications

Master's degree in Life Sciences or related field.
Typically 3 years of QA or manufacturing experience in pharma/medical devices with batch record review and investigations.
Knowledge of GMP, GDP and/or GCP.

Responsibilities

Review batches to support QP batch certification per EU/international regulations.
Approve clinical label artwork.
Assess temperature excursions during transport and at sites.
Resolve compliance and quality issues in manufacturing and transport.
Review and approve minor deviations and ensure procedural requirements.
Own and generate SOPs and Work Instructions.
Review SOPs to meet Corporate, Site and Regulatory requirements.
Prepare monthly metrics.
Identify issues and work cross-functionally to resolve.
Support Clinical Packaging and Labelling Operations as QA on the floor; perform pack checks, batch record reviews and issue handling during manufacturing.