Senior Associate QA

Breda, reference 2025-01907

Job description

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

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.

Working conditions

• A challenging work environment with excellent career development programs.
• Hybrid position, but at least 3 times per week on site in Breda.
• For this role, the company offers a competitive salary package.
• Reimbursement of travel expenses is dependable on travel distance.
• The contract will be through Undutchables.

Work location

Breda

Company description

Our client is an international market leader in the pharmaceutical industry – focused on transforming science and biotechnology into therapies that have the power to restore health or save lives. The patients are the main priority at all times. This USA founded organization holds a large site in Breda, where produced medicines are labeled, stored and shipped worldwide, to more than 75 countries. The staff in Breda works on supply chain processes, engineering, clinical research, marketing and sales on a daily basis. The company culture is dynamic and fast paced, with a strong international character.

Good to know

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Recruiter contact

Kelsey Persch, Eindhoven
kelsey.persch@undutchables.nl
+31(0)6-34154093