Business Test Lead, and including multiple partner teams/systems Define, plan, organize, manage and track all related test activities Prepare and conduct test phases entry- and exit meetings Report on
Erstellung der Reports für den CFO Die monatlichen Finanzkennzahlen analysieren Den Budgetprozess der Produktionswerke sowie die Plausibilisierung der Planung begleiten Nachverfolgung
in collaboration with the Quality Manager Quality review of deviation reports and corresponding corrective actions, change control reports, and SOPs Maintenance and update of electronic databases (list of contacts
Management of cleaning verification activities as well as support and representation of the GMP officer Preparation of the relevant documentation (assessments, protocols and reports) for cleaning
des Betriebes unter Berücksichtigung aller regulatorischen Anforderungen sicher Auslösen, Bearbeiten, Beurteilen und Genehmigen von Deviation-Reports (Abweichungsberichte), CAPAs und Changes
, Beurteilen und Genehmigen von Deviation-Reports (Abweichungsberichte), CAPAs und Changes in der entsprechenden IT-Anwendung (TrackWise) Review und Genehmigung von SOPs und anderen GMP-Dokumenten
Report (CSR) Medical training of the Clinical Trial Team (CTT) members and/or my clients staff Medical oversight of the study (including safety, quality and performance of the trial) Clinical Trial
biometrician in the study-implementing teams of the clients Creating analysis plans Carrying out and / or monitoring the analyzes Cooperation in the report preparation Development of programs for the
basis Manage the global flow of intermediates (flakes) Report on supply chain indicators Achieve supply chain excellence Provide logistics management Profound experience in a similar position
test protocols and reports, execute IQ, OQ, and PQ etc.) Ensure compliance with international regulations (GMP, SHE, pharmacopoeias, authorities, requirements) Maintenance of packaging solutions (e.g
expertise in epidemiological methods arena, contributes to external congresses and meetings Accountable to write study synopses, protocols and related documents (Case Report Form (CRF) content), using
systems, tools and reports Create and maintain centralized project/team work-spaces, including document creation and/or maintenance Assist with effective communication and information sharing via
in DMPK, clinical and study management sub-teams Review protocols and guide project teams in all aspects of bioanalytical work required for the project Review data and reports for regulatory submissions
and practices Review CMO stability protocols and reports Support analytical transfer activities (e.g. support in providing documents, samples, reference standards) Contribute to the elaboration of
, Telepresence and meetings with iHCP (Healthcare professionals)) following compliance guidelines Type documentation, e.g. agendas, presentations, minutes etc. and file information such as reports and literature