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Senior Associate QA

UndutchablesEindhoven

2 dagen geleden

Salaris

€ 52.000,00–€ 55.000,00 jaarlijks

Functieomschrijving

We are seeking a Senior Associate QA to provide quality oversight for equipment validation, packaging qualification, and PASX master data management. This role ensures compliance with GMP, corporate, We are seeking a Senior Associate QA to provide quality oversight for equipment validation, packaging qualification, and PASX master data management. This role ensures compliance with GMP, corporate, and regulatory requirements while supporting validation, change control, and deviation management processes.

Key Responsibilities :

Review and approve validation documentation for equipment, processes, and systems.
Ensure GMP compliance for equipment changes and provide QA guidance for technical assessments.
Review and approve master data in the PASX electronic batch record system.
Conduct final QA review of technical change controls and validate assessments from multiple stakeholders.
Act as QA contact for deviation records and ensure compliance with quality standards.
Manage device and combination product responsibilities, ensuring alignment with GMP regulations.

Requirements :

MBO or Bachelor’s degree in Life Sciences, Process Technology, or equivalent.

Minimum 3 years in the pharmaceutical or medical device industry with a focus on equipment and automation validation.

Strong understanding of GMP, equipment validation, automation systems, and computer compliance.

Logical problem-solving, risk-based decision-making, and effective communication at multiple organizational levels.

Fluency in English, both written and verbal.