Friedberg, Hesse, Germany
I have extensive experience as auditor to qualify and support suppliers performing audit on routine basis. Moreover I have previous experience in quality assurance related to the management of CMOs performing several activities to maintain the GMP compliance interacting on a global level with markets, local and global regulatory as well as european CMOs. I hold a PhD in Chemistry with a strong expertise in material analysis and beside also a strong background as consultant, expecially in ISO 14001 and ISO 9001 certification.
• Active support and promotion of achievements of the company regarding Quality Assurance in collaboration with other facilities and departments • Perform on-site GMP audits to review the compliance with regulations and quality requirements at Plasma suppliers and service providers • Preparation, conduction and performing of follow-up course work of audits at Plasma suppliers and service providers • Preparation of audit reports including CAPA, monitoring returns of CAPA and evaluation of CAPA actions • Support the Plasma and service suppliers with recommendations to improve the compliance with GMP regulations • Promotion consistency among the group by reviewing audits reports recommending changes as necessary • Collaboration with Country Experts in order to support them in customer care in all quality aspects
•Support implementation and continuous improvement of quality processes and procedures required to ensure GMP expectations for GSK external suppliers are met, for example (not inclusive): change control, quality agreements, Complaints •Support monitoring and analysis of quality performance of the External Suppliers using quality tools (e.g., Pareto charts). Examine external suppliers’ key process indicators to propose continuous improvement initiatives. •Study and modeling of stability data available for the products managed to foresee the commitment to the market specific product shelf life, the supply and the regulatory compliance •Perform direct management of a few external suppliers, as applicable. This includes negotiation and development of Quality Agreements; implementation of Quality key performance indicators at the external suppliers. •Ensure regulatory compliance for new product introductions and transfers by establishing liaisons and performing actions with GSK Regulatory groups and external suppliers to register and maintain product dossiers, identifying compliance gaps and managing the mitigation process • Request required legal documentation such as CPP, GMP certificate, Legalized and Notarized Declarations and documents as required by for LOCs for registration and renewal purpose. •Communicate with the Quality Managers to ensure that potential quality issues are identified and that the support is provided to resolve with appropriate sense of urgency •Liaise with key contacts at the External Supplier to ensure relevant and applicable outcomes from quality & manufacturing systems, such as batch records, deviation investigation, change controls, validations, Annual Product Reviews (APRs), and product disposition are robust to ensure product quality •Maintain (external suppliers) customer product complaints system to address complaints in a timely fashion •Support in CAPAs, Quality Alerts, risk assessment •Support in Distribution Risk Assessment
• Validation and checking of the quality documentation • Auditing and support in the renewal of the ISO 9001 certification • Management of nonconformities and CAPA • Support in the formulation of tenders for the acquisition of the contract notices which the company participates
• Implemented systems responding to the international standards ISO 9001 and ISO 14001 • Created checklists for legal and environmental compliance • Follow up of the environmental certification of clients • Auditing of the client processes to obtain and renew the ISO 9001 and ISO 14001 certification • Organized training courses for customer personnel