« The time for action is now.
It’s never too late to do something.»
– Antoine de Saint-Exupéry
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.
Analysis of business processes and overseeing the implementation of defined actions; optimizations in local and global Quality Management; training of Q-Tools; introduction of Lean Management. Definition and implementation of a customized, efficient Lean Organization.