About
We are experienced Quality professionals who have been working in the pharmaceutical industry both in large investment projects as consultants but also as internal employees for pharmaceutical manufacturers.
This gives us the unique ability to bring you the knowledge from both worlds and to see past the project at hand to know what wheels are turning behind the scenes, for what it takes to release the facility for GMP manufacturing and what you need to stay compliant during the life cycle.
We have worked with Equipment and Process for Biotechnology (up- and downstream), Aseptic and Sterile Fill Finish Facilities, Solid Oral Dosage Forms, Liquids, Creams and Ointments, API manufacturing, Human blood-based products, and LBP’s.
We are experienced in designing and implementing lean but compliant Engineering, Commissioning, Qualification and Validation Strategies.
We have been Hosting & Participating in > 50 Audits in active roles in the front office for health authorities (Swissmedic, RHI and FDA) as well as for various customers.
With our professional expertise we are motivated by creating results, improving concepts and processes, together with your team, with respect to your company culture and journey.
Azimuth Quality is your competent partner in the field of Engineering Quality, for the implementation of legal requirements in the pharmaceutical and life science industry. We provide you, your external Engineering Quality department, with all the knowledge that you need in projects and in routine manufacturing to stay compliant.
Who We Are
Our Approach
In the pharmaceutical Industry there are a handful of concepts that are of special interest in every audit. This is the pharmaceutical quality management system (QMS), your cleanrooms with your manufacturing process, the analytical set up and the release of your product and finally the Qualification of your Equipment, Media, Facilities, the Validation of your Processes and the release for GMP.
We as Azimuth Quality span the horizon with deep Engineering Quality know-how and are able to provide you the support that you need to successfully achieve right first time results.
Azimuth Quality helps you to achieve the overall Engineering Quality concept from projects and initial site release through to routine manufacturing.
In parallel with you and the Project Team, we can help you to set up your documentation structure, timelines and interdependencies of the different workstreams in your project. We provide you with the knowledge and references of the regulatory requirements applicable to you, templates and examples as well as our lessons learned from previous projects and audits.
Our Team
Lead by a strong senior consultant with 10+ years of experience heading Qualification/Validation and Engineering Quality departments, we are well experienced in the pharmaceutical industry and bring you a high level of execution power and a distinct end-to-end business, process, and quality understanding.
