Equipment Quality Assurance Coordinator

As a quality equipment specialist consultant, you will contribute to ensuring that our equipment lifecycle processes meet the highest quality standards. From supporting the selection and qualification of equipment to maintaining compliance with regulatory requirements, you play a key role in upholding operational excellence. You’ll collaborate with cross-functional teams, tackle challenges related to equipment validation, and ensure adherence to cGMP and industry best practices. Your expertise will help us maintain a robust quality framework while driving continuous improvement in our processes.

What You Will Do:

• Provide: quality oversight and approval for equipment lifecycle documentation, including URS, DQ, IQ, OQ, PQ, and change control.
• Collaborate: with engineering, CQV, and maintenance teams to ensure equipment meets intended use and quality standards.
• Review: commissioning and qualification protocols and reports for compliance with cGMP and relevant guidelines.
• Ensure: critical equipment and instrumentation are calibrated and maintained according to approved procedures.
• Support: audits, inspections, and deviations by providing relevant equipment documentation and subject matter expertise.

At the company, we believe in empowering our employees by offering a supportive environment that fosters professional growth and personal well-being. Here’s what you can expect when you join our team:

• Monthly salary between €6,000 and €8,000.
• Temporary contract with potential for extension.
• Full-time role, 32-40 hours per week.
• Hybrid working model with 2-3 days in Leiden office.
• Focus on your health and well-being through tailored benefits.
• Opportunities to contribute to groundbreaking pharmaceutical innovation.

We are seeking a detail-oriented Quality Equipment Specialist with a strong background in pharmaceutical or biotech industries to ensure compliance and excellence in equipment lifecycle management.

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 5+ years of experience in quality, validation, or engineering roles.
• Strong knowledge of cGMP, FDA 21 CFR Part 11, ISO 13485.
• Experience with equipment validation and qualification processes.
• Familiarity with calibration systems, CMMS, and quality systems.

Welcome to the company, a pioneering biotech company located in Oegstgeest. With a mission to transform lives, we focus on unmet medical needs through innovative science and technology. Our commitment to challenging the status quo drives our deep pipeline of best-in-class medicines.

At the company, we foster a collaborative work environment that emphasizes continuous growth and empowerment. Join us in shaping the future of healthcare, where your ideas and expertise will contribute to meaningful advancements and impact.