Peter Imre

Professional supervision and line management of manufacturing and packaging technology teams Direct and supervise external and internal technology transfers and process validation of sterile products Managing product life cycle, leading optimisation and process robustness improvement projects of sterile manufacturing technologies Act as key liaison for other business partners (QA, R&D, Regulatory Affairs, Supply Chain and Operation) locally and globally

Accomplished the implementation of a new original small molecule API at the production site Scheduled production program according to commercial demands Assured the production of small molecule bulk APIs and intermediates according to the cGMP Actively participated in a successful FDA inspection and different customer audits

Coordinated the technology transfer (scale-up, trial batches and process validation) of 12 small molecule APIs and 2 key intermediates between Hungary and India Liaised between the concerned Indian and Hungarian QA, Technical, Logistics and R&D teams Reviewed production and validation documentation and supported regulatory filings Achieved manufacturing site approval by the national authorities Scheduled and regularly reported technology scale-up projects

Assured the production of small molecule bulk APIs and intermediates according to the cGMP Reviewed executed batch records prior to batch release and participated in the compilation of the annual product review dossier. Prepared several production related SOPs, work instructions and master batch records Coordinated the installation and qualification of a new centrifuge and distillation column