Dipl.-Ing. Önder Thomas Sever

• Qualification of Laboratory & Process equipment, Rooms, Infrastructure • Commissioning & support with URS, Specifications • GMP Compliance consultancy/support • Internal standardisation, templates, e.g. Change Control, URS, RIA • Execution and consultancy for Change Control, CAPAs, Risk Assessments • Stakeholder management, management of expectations and priorities • Enaio (Documents), BizzMine (Changes)

• Consultancy on Qualification strategies • GMP Compliance Consultancy (internal / external) • Qualification projects for equipment / utilities / infrastructure • Templates for specifications, qualification plans and high-level QM-documents e.g. URS, FMEA, Traceability Matrix, project plans, QMP, SMF • Change Control, CAPAs, Deviations, Risk Assessments • Stakeholder management, management of expectations and priorities • MS-Project, COMOS, SAP

• Qualification projects for machines / utilities / infrastructure with responsibility for schedules, budget, external manpower, quality • Responsible for GMP compliant documentation in Engineering dept. • Change Control, CAPAs, Risk Assessments • Preparation / support of inspections • Templates for qualification plans, URS, FMEA, Traceablity Matrix • Internal GMP trainings, internal inspections • Stakeholder management, management of expectations and priorities • MS-Project, Lotus Notes, IFS (ERP)

Abt. MSAT Packaging & Warehouse (Bau 232) • Subject Matter Expert (SME) for tests, risk analyses, equipment qualifications, validations • Stakeholder management (Production, Engineering, MSAT, QA) • Technical change management and support for the implementation of the new change control database (TrackWise) at packaging site • Coordination of supplier visits and machine FAT, SAT • Temperature mappings of rooms and machines • MS-Access, Visio, TrackWise, Documentum

• Coordination of technical changes, support for maintenance visits on site • URS, FAT/SAT documents for blister machines, cartoners, labellers, printing systems, optical systems etc. • URS-Template for purchasing department and qualification department • Supplier visits and machine acceptance tests on-site und off-site • Technical translations D <--> E • Qualification of pharmaceutical packaging machines (blisters, bottles, sachets), high-purified media (water, steam) • MS-Project, AutoCAD, SAP, Documentum

• Qualification of incubators, H2O2 vaporiser, vial washer, isolators, refrigerators and other laboratory equipment • Temperature mappings of laboratory equipment and vessels, ultra-low freezers and hot-air sterilisers • OQ execution for compressed air and pure steam • Filter leakage tests and PQ execution for the qualification of cleanrooms • PQ sampling of purified water and pure steam • MS-Office, Access, Visio

• Mitarbeit bei der Entwicklung und Optimierung eines Prozesses zur Abscheidung homogener Kupferschichten auf Siliziumwafern • Planung, Durchführung, Auswertung und Dokumentation von Versuchsreihen, Literaturrecherchen

Studienschwerpunkt Bioverfahrenstechnik