Eric Reichardt

QA Operations DP - Quality Oversight activities in liquid vial filling line & production service departements ( including dispense center, API-handling, visual inspection systems, hygiene services) at Roche's sterile drug product manufacturing site in Mannheim - Change Management - Deviation Management - CAPA Management - QRM - Crossfunctional management of controlled/regulated documents - SME external audits - self inspections - GMP-Auditor - Reporting - Management of quality documents

MSAT -Equipment Qualification -Planning & crossfunctional coordination of performance qualifications & other qualification activities/projects -Crossfunctional coordination & management of controlled/regulated documents -Evaluation of new methods in qualification & requalification -Implementation of new technologies -Launch Tecentriq -Management of qualification documents -SME internal/external Audits -Change Management -Deviation Management -Reporting -Business Process Manager -Auditor

- Implementation of robust process operations for single-use disposables as part of start up of trayfiller filling line (TFM) - representive of user group of new manufacturing module, using isolators, E-Beam and disposable technologies in compunding and aseptic filling - Crossfunctional collaborations with internal/external business partners - Implementation of new process operations - SOP Management - Batch record - Optimization of process operations - Trainer/Supervisor for apprentice

- Sterile filling of parenterals (lyophilisates, liquids) - Aseptic compounding - Equipment preparation for sterile manufacturing - Launch Perjeta - Launch Gazyva/Gazyvaro - Batch record - SOP - Trainer/Supervisor for apprentice

Industriemeister, Fachrichtung Chemie, Fachspezialisierung: Technologie, AdA,