Nils Weiler

Qualification of equipment and devices Validation of methods and processes Writing, interpreting and reviewing technical documents required for different stages of product lifecycle Interface to external laboratories Continuous improvement projects Project management Personnel management Design of Experiment Gap analysis with relevant norms and standards Impact analysis for inspection observations Analysis of the feedback from the relevant market

DeltaSci Solutions bietet Unterstützung und Beratung für die Life-Science-Industrie. Wir sind Experten für Qualitäts- und regulatorische Fragen sowie für Aufgaben technischer und wissenschaftlicher Art.

- analytical method development and validation in accordance to ICH guidelines - MDR transition (CMR, ED, ADC) - QC Lab supervision, driving continuous improvement initiatives - Process owner in QMS landscape - Equipment ownership (GC-MS, HPLC, ICP-OES, FTIR and more) - cleanliness analyses (ISO 19227) and chemical characterization (ISO 10993) - subject matter expert in CAPAs, NCRs, audit situations (MDSAP, BSI, FDA and more) and product submissions (CE marking, PMA, 510(k))

- project management - driving continuous improvement initiatives (Lean, 5S) - subject matter expert in OOS/NC/CAPA situations - compiling and reporting of submission-relevant data

- setting up fully equipped analyses labs - insourcing of analyses methods (ASTM, USP) - establishing process for manufacturing material evaluation (CFR) - commissioning and maintenance of analytical instruments (GC-MS, TOC, FT-IR)