About Fusteros
Our Mission
Provide scientific and technical solutions that optimize our customers' manufacturing processes, reduce production costs, and ensure the highest standards of quality and safety.
Our Vision and Values
Quality and safety: We are committed to delivering excellence and ensuring safety.
Base our decisions in science: Our success relies on continuous improvement, guided by the scientific method. We prioritize well-designed experiments and data analysis to inform, and rational decision-making.
Integrity and ethic: We maintain the highest ethical standards in all we do, ensuring we act in the best interests of our customers and our communities.
Trust and Respect for People: Every job and every person matter. We foster a culture of diversity and mutual respect.
Teamwork and Leadership: We lead by example and take pride in what the team do. We inspire others reach their full potential and work together to generate the best decisions for customers and their patients. Leader and team members will all be accountable for the results and for implementing the decision in a timely manner.
Science-Based Solutions for a Better Tomorrow
Our team brings extensive experience in the Biopharmaceutical and Medical Device industries, specializing in semi-automated, automated, and large-scale manufacturing and assembly operations.
Our personnel possess strong expertise in regulated industries, with hands-on manufacturing processes, equipment design, validation, and quality control.
Our team specializes in managing and supporting new product design and product launch. We offer comprehensive assistance with tasks such as change control assessments, approval of specifications, testing of raw materials and designing complex products, including drawings and artwork.
Additionally, we have extensive experience in designing and implementing new machine recipes.
Our team excels in designing machine parts and assessing their impact on product and equipment qualification status. We also specialize in leading and executing protocols for parameter characterization, completing post-approval and delivering reports.
We will coordinate all project phases with both internal departments and external suppliers to ensure seamless implementation and success.
Fusteros personnel are equipped to manage change control assessments for Commissioning and Qualification. Evaluating new equipment designs. Generating, reviewing, and approving design documents, as URS/DS. Developing and executing qualification and validation protocols, for FAT, SAT, IQ, OQ, and PQ. Supporting test execution completing post-approval and reports.
We can handle your essential business support activities including conducting Failure Mode and Effects Analysis (FMEA). Providing technical assessments, and performing non-conformance investigations. Defining and implementing preventive and corrective actions (CAPA).
We work identifying and implementing process improvement opportunities using structured, data-driven methodologies such as DMAIC, 6S
