Sema has more than 12 years of experience in the pharmaceutical industry. Working in Xellia with different roles from Compliance specialist, production specialist, GMP documentation specialist, Senior Aseptic processing specialist, has made Sema an experience all round profile around the aseptic processing disciplines.
She has a wide range of competences working with daily production, process equipment, changes and validation, optimization and project lead, where she has been responsible for:
โข Deviations and systematic problem-solving
โข Change request, with or without regulatory impact
โข Risk evaluations: QRM, CARA, FMECA, EHS, OHS
โข Numerous validations setups and experienced Engineering Responsible and
Operation Responsible
โข Requirement setting for new processes or equipment
โข Verification steps as DQ, FAT, SAT, IV, OV, testing and PFV
Xellia, Denmark โ 2022-2023
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