Head of Quality Management/Quality Assurance

4/2024 – offen

➢ Supervision of the QMS under DIN EN ISO 9001
➢ Supervision and implementation of calibration laboratory under DIN EN ISO/IEC 17025
➢ Management of CAPAs/Deviations/Changes/Complaints
➢ Implementation of GAMP 5 2nd Edition
➢ Develop, maintain and implement the quality systems to ensure product reliability, quality, efficacy and compliance to applicable SOPs
➢ Trend analysis of quality results and intervention as appropriate
➢ Lead Auditor: regulatory inspections and customer audits/ internal and external audit program
➢ Management Review
➢ Management of 21 CFR Part 11 compliance
➢ Preparation, implementation and follow-up of external customer audits and inspections by authorities
➢ Supervision of the training management system
➢ Quality Management Representative

Qualitätsmanagement / QS / QA (IT)

1/2023 – 3/2024

➢ Plan and direct the implementation and maintenance of the quality systems
➢ Manage processes centred around quality documentation, training, contractor management, and GMP compliance functions
➢ Manage and perform quality audits and follow up
➢ Manage the supplier qualification program
➢ Manage regulatory inspections and customer audits
➢ Manage the internal and external audit program
➢ Participate in the review of product release/rejection
➢ Review of batch records and preparation of batch releases
➢ Develop, maintain and implement the quality systems to ensure product reliability, quality, efficacy, compliance to applicable SOPs, GMP regulations
➢ Independent review and approval of deviation and investigation documentation. Including thorough evaluation of the root cause and the ability to effectively communicate to individuals in the science and manufacturing departments
➢ Communication directly with department heads, subject matter experts and suppliers relating to quality matters
➢ Streamline and improve systems
➢ Staying abreast of regulatory updates and guidance to ensure compliant processes and procedures
➢ Trend analysis of quality results and intervention as appropriate
➢ Follow-up and resolution of customer complaints
➢ Ensuring compliance of systems and procedures with corporate procedures

Qualitätsmanager

7/2021 – 12/2022

➢ Review of batch records
➢ Preparation of batch releases
➢ Supplier qualification and supplier management
➢ Preparation, implementation and follow-up of external customer audits and inspections by authorities
➢ Co-preparation and review and approval of controlled quality-relevant documents
➢ Validation documents, risk analyses, SOPs, changes, deviations, plans, reports and OOS
➢ Supporting the further development of the quality management system
➢ Training of employees
➢ Contact person for qualified person, quality control, production and filling employees
➢ Ensuring compliance with regulatory

Qualitätsmanager