Elisabeth Mertin

- Batch disposition for bulk and finished products - Approval of quarantine shipments for bulk and finished products - Decision of non-critical and critical deviations and definition of CAPAs - Regulatory Compliance Check - QA oversight in process unit - Review of APR/PQR

- Technical supervision of manufacturing of bulk products especially for roller compaction products - Investigation of non-critical and critical deviations - Definition of CAPAs - Handling of SOPs - Lead and support of validations, re-validations and AMB - Support of launch activities - Support of health authority inspection activities (FDA, RHI etc.)

- Single point of contact for microbiological testing (Microbial Enumeration Test) for oral solid dosage forms/ semi solid dosage forms/ inhalation products and for excipients - writing of risk assessments - Review of testing monographs - Handling of OOE/OOS results - Handling of SOPs

Molecular Ecology