Brigitte Schoy

Background

About Brigitte Schoy

Current position: Quality Engineer Experiences gained- Ensuring compliance with regulatory GMP and FDA guidelines as well as industry standards and internal regulations - International project experience in the pharmaceutical industry (commissioning, FAT, SAT, qualification (DQ, IQ, OQ, PQ) and validation)- Group leader of a task force to implement a routine monitoring process according to Annex 1 and a PQ strategy for gas systems – Experience with pharmaceutical process systems as well as cleanroom technology, pharmaceutical water (WFI, PW, clean steam) and gas systems (compressed air, N2)- Optimization of existing qualification strategies - Creation and verification of deviations, CAPAs or change requests - Evaluation of qualification/validation-relevant topics in the context of change control or deviation management - Collegial cooperation with other relevant departments such as technology, hygiene, production, automation, design and external suppliers/service provider Education- Bachelor of Science in hygiene technology at university of Albstadt–Sigmaringen Wants in the future- Interesting contacts