Reference 1
… was very satisfied with the Phase 1 – Gap Assessment outcome. In spite of the complexity of involving both internal resources and external professionals so intensively during 3-4 weeks, we feel that there was a lot of professionalism applied … Moreover, the report was quite clear, with necessary description of findings that were the basis for the conclusions, associated with a very helpful resource calculation for the remediation activities. … is now engaged to sponsor a big project to consolidate the … manufacturing sites … From this perspective … the produced report we have in hands will be used as a trustful source of information.
Reference 2
Dear Dr. Vavrecka, you contributed substantially to the preparation of the FDA / IKS pre approval inspection for the AIDS medication ….. In appreciation of your extraordinary effort we award you …. We thank you for your great contribution and wish you further satisfaction and success …
Reference 3
Dear Dr. Vavrecka, Medication X is an important product for our corporation and a cornerstone in our future portfolio … with your committed efforts you substantially contributed to the successful launch of Medication X. We thank you for your achievements and are pleased to award you with ….
Reference 4
In 2015 Mojmir Vavrecka led a cGMP readiness project across the four Swiss manufacturing, packaging and warehousing sites: In the first phase of the project a detailed investigation was executed (4 auditors, 3 weeks) resulting in a gap assessment report over all sites. The findings of this report combined with findings of other audit reports of the last 10 years were summarized and build the baseline for a two day work shop with 30 internal experts. As a result an action / project plan for all remediation activities with estimated cost and resource needs was developed to support … future GMP strategy. All these documents were used as starting point for a subsequent and urgent RHI-readiness project in 2016, also led by Mojmir. … Mojmir Vavrecka is a distinguished professional and result oriented leader with a strong quality background. As a team member and project leader Mojmir had a very positive and collaborative character combined with many other soft skills e.g. team-building, problem solving, etc., which were strong enablers for the project success. It was a real pleasure to work with him and I wish him all the best for his future projects.
Reference 5:
In 2013-2014 Mojmir Vavrecka led a cGMP readiness project at … starting point for a subsequent FDA Readiness project in 2014, also led by Mojmir. … As a team member and project leader Mojmir had a very positive and collaborative character, which were strong enablers for the project progress and success. The FDA inspection took place in June 2016 and was successful without issuance of a 483 form. …