Clinical QA Batch Release Specialist

Sire Search

Breda

On-site

EUR 58,000 - 82,000

Full time

3 days ago

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Job summary

Sire Search in Breda is seeking a QA Batch Release Specialist to provide Quality Assurance oversight for Investigational Medicinal Products across the clinical supply chain. You will participate in batch reviews for QP certification, oversee labeling, and ensure compliance with GMP, GDP and GCP requirements.

You will collaborate with Clinical Supply Chain, Warehouse and Distribution, Production, and Regulatory Affairs, review deviations, contribute to SOPs, and prepare quality metrics while

Qualifications

Typically 3+ years of QA or pharmaceutical/medical device manufacturing experience.
Experience with batch record review and investigations.
Knowledge of GMP, GDP and GCP is essential.
Strong communication skills and fluent English required.

Responsibilities

Perform batch review to support QP certification and regulatory compliance.
Review and approve clinical label artwork from a compliance perspective.
Assess temperature excursions during transportation and at clinical sites.
Support resolution of compliance and quality issues in clinical product manufacturing and transportation.
Review deviations and ensure procedural requirements are met.
Create and maintain SOPs and Work Instructions.

Skills

QA experience

Batch record review

Investigations

Compliance awareness

GMP knowledge

GDP/GCP knowledge

Strong communication

Fluent English

Education

Master of Science in Life Sciences

Job description

You will collaborate with Clinical Supply Chain, Warehouse and Distribution, Production, and Regulatory Affairs, review deviations, contribute to SOPs, and prepare quality metrics while

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