Quality Assurance - Random Lake, United States - Infinity Systems

Infinity Systems
Infinity Systems
Verified Company
Random Lake, United States

3 weeks ago

Meredith Sinclair

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Meredith Sinclair

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Description

Join our team in Munich, Germany and become a QA/RA professional at our dynamic department, with a focus on API.

This role is not just about daily operations, but also about leading the improvement of our QA/RA system to enhance the efficiency of our entire department.

We are seeking a visionary team player who excels in long-term planning and continuously strives to enhance our Quality Management System, both internally and externally.

Your main responsibility will be active pharmaceutical ingredients (API).

Your QA Responsibilities:

Immerse yourself in the world of GMP and GDP regulatory requirements, creating, reviewing, and maintaining fully compliant SOPs.

Take charge of organizing and supervising the execution of our QMS, ensuring smooth operations throughout the department.

Coordinate and manage the assessment and evaluation of our suppliers, manufacturing partners, warehouses, QC laboratories, distributors, transportation companies, and other service providers to ensure their compliance with the highest quality standards.

Conduct audits of suppliers/contract manufacturers and warehouses, leaving no stone unturned in verifying their adherence to GMP/GDP standards.

Prepare and assist with authority inspections and customer audits of manufacturers, ensuring our partners maintain the highest level of compliance.

Collaborate with cross-functional teams to develop and implement quality agreements with customers and suppliers.

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