Mateusz Irzykowski Email & Phone Number

Vietnam

- Creating Strategy for Computerized systems implementation - Manage project for implementation of MRP, CDS, EMS any 3 letter abbreviation systems into factory operation. - Leading project planning sessions - Participation in the computerized systems purchasing process and reporting on the implementation of the CAPEX and OPEX budget - Designing risk mitigation plan - Optimizing and improving processes and the overall approach where necessary - Managing large and diverse teams - Supervision over validation tests for computerized systems - Maintaining computerized systems in the validated status and according to the current GxP requirements - Supervision over Implementation new informatic systems and application - Participation in inspections / audits GxP – internal and external - Working with IT development teams to build out new capabilities to streamline daily operationsidentifies any potential CFR part 21 part 11 or GMP annex 11 gaps and ensures that the best csv and data integrity practices are enforced. - Maintains awareness of global and site policies/procedures and applicable external regulations to ensure business processes meet compliance requirements.

Vietnam

- Drafting and assessing documents related to the implementation and operation of a quality system at the QC Laboratory (procedures, analytical methods, protocols, specifications)- Maintaining work discipline, ensuring effective use of working time, communicating problems when carrying out analyses and risks resulting from the failure to execute a plan- Planning quality control activities- Leading and taking part in OOS/OOT/OOE investigations- Training of employees concerning new SOPs and interpretation of GMP requirements- Transfer, optimization and validation of analytical methods- Executing and coordinating the transfer of analytical methods provided from other laboratories. Providing analytical input to the implementation of new products- Solving day-to-day problems related to testing and measurement equipment- Advising and executing VMP for Quality control laboratory equipment in terms of EU regulations- Supervising introduction of EU requirements in relation to Computerised systems in Quality Control- Performing audits at the QC area- Initiating and implementing improvement measures

Pabianice

- Drug analysis by HPLC according to GMP, GLP requirements.- Administration of the Empower3 system.- Implementation of automatic calculations using Custom Fields in the Empower3.- Preparation of reports, solving problems related to software.- Leading and taking part in OOS/OOT/OOE investigations