QA Batch Release Specialist

Sire Search; Breda; On-site; EUR 58,000 - 82,000; Full time

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

The Company

A leading global biotechnology organization focused on developing and delivering innovative medicines for patients with serious illnesses. Its Breda operation brings together more than 1000 employees representing 38 nationalities across manufacturing, supply chain, commercial activities, and clinical research.

About the Role

The QA Batch Release Specialist provides Quality Assurance oversight for Investigational Medicinal Products throughout clinical supply chain activities. The position supports batch review for QP certification, clinical labeling, temperature excursion assessments, deviations, SOPs, and quality activities within clinical packaging and labeling operations. The role works closely with Clinical Supply Chain, Warehouse and Distribution, Production, Site Quality, Clinical Research Management, and Regulatory Affairs.

Responsibilities

• - Perform batch review to support QP batch certification of Investigational Medicinal Products according to EU and international requirements
• - Review and approve clinical label artwork from a compliance perspective
• - Assess temperature excursions occurring during transportation and at clinical sites
• - Support resolution of compliance and quality issues associated with clinical product manufacturing and transportation
• - Review and approve minor deviations and ensure procedural requirements are met
• - Create and maintain operational SOPs and Work Instructions
• - Review SOPs against corporate, site, and regulatory requirements
• Prepare monthly quality metrics
• - Identify quality issues and collaborate cross functionally on solutions
• - Provide Quality Assurance support within clinical packaging and labeling operations
• - Perform packaging checks and batch record reviews
• - Support issue handling during manufacturing activities
• - Execute QA compliance checks on the production floor

Requirements

• - Master of Science degree, preferably in Life Sciences or a related discipline
• - Typically at least 3 years of relevant Quality Assurance or pharmaceutical or medical device manufacturing experience
• - Experience with batch record review
• - Experience with investigations and analytical testing
• - Knowledge of Good Manufacturing Practice
• - Knowledge of Good Distribution Practice and or Good Clinical Practice
• - Strong understanding of compliance and quality requirements
• - Strong communication skills
• - Fluent English