Quality Expert

Many years of experience in quality control, especially testing and analytics of sterile, biological medicinal products

Profound knowledge of national and international GMP regulations, their requirements, and their implementation in the quality control area

Sound knowledge & experience with a variety of analytical methods, e.g. protein analytics, and their validation

Testing of sterile & biological medicinal products, among others

Use decision of finished products as dosage forms sterile products - aseptic production

Assessment of deviations, complaints, product quality assessment (PQR)

Registered as Back-Up Qualified Person (Bavaria, Government of Upper Franconia)

Project work (advice on individual projects from a pharmaceutical and quality point of view)

Usage decision

Selection and evaluation of raw materials and finished products for use in sterile dosage forms (sterile solutions, freeze-dried products)

Technical management of teams (sampling, QA raw material and merchandise)

Release of raw materials, assessment of deviations, cooperation with internal and external laboratories

Release of finished products, commercial goods; sterile solutions and freeze-dried products as dosage forms

Assessment of deviations, cooperation with contract manufacturers

Consulting Team "Operations I“

Performing tasks of the quality department: In the overarching product compliance project (internal QA team, cooperation with external laboratories and contract manufacturers), in projects of the "Development" department, in compliance checks (process and method validation); qualified person if necessary

Supervision of a production plant (solids, tablets), product release, assessment of deviations

Concept and implementation of an improvement project for the release lead time