Leading (cross-functional) Projects and drive planning, stakeholder management, communication, dependencies & risk management. Preparing, moderating and post-editing workshops as well as supporting the creation of management reporting and presentations that serve as decision-making basis for e.g. the Executive Board.
Efficient, sustainable support in Audit Management & preparation / monitoring for Health Authorities Inspection, CAPA Management, Documentation, Risk Management, PQRs, Qualification / Validation, Deviation & Complaint Management. Interim QP/RP (FvP) according to Swissmedic Regulation (AMBV). Ensuring to fulfill all requirements according to GMP / GDP / GCP / GLP as interim / external Manager QS.
Preparations (GAP analysis, definition and follow-up of actions) to important audits according to ISO9001, IATF16949, ISO14001 and specific customer audits. Establishment of management systems and creation/improvement of documentation based on these standards. Optimizations in local and global QM-topics.