Munich, Bavaria, Germany
My views are my own
Coordination of intra- and inter-departmental Quality activities Investigation / assessment / follow-up of non-conformities (e.g. deviations, product quality complaints) Definition and follow-up of change controls and CAPAs Creation and revision of GMP/GDP relevant SOPs Coordinate review and approval of SOPs with the functional areas and global quality management in the electronic document management System Participation in validation activities for Trackwise system and review of related documents
GMP Auditor at Sandoz International, Holzkirchen, Germany. Main activities: GMP and Quality system audits at Sandoz and third party manufacturing sites. Monitoring of CAPAs, trending and follow up of audit findings. Support of training session and risk assessments.
Main activities: Batch Release, Investigation and writing up of Deviations and Chemical Failures not process related according to company procedures (SOPs), revision and writing up of SOPs, writing of Annual Product Quality Review (APQR), participation in Ministerial/FDA inspections, use of LIMS, MAPS and Track Wise (QTSv3) softwares. Team member in a project for Electronic Batch Recording (core solution based on PMX-Rockwell). Previous activities: Process Validation, Investigation and writing up of Process Deviations and Chemical Failures, revision of APQR.
Starting up of laboratory instruments, quality control tests on production and raw materials, non conformity management, management of external laboratories analysis.