Experience

SCOPE International

• Germany
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Head of Quality Management

  • Oct 2015 - Present

  Mannheim QMS management including SOPs, vendors, in-house audits/inspections, CAPA Performing internal and external audits Compliance advice for operational staff

• Auditor

  • Feb 2008 - Oct 2015

  Ongoing online investigation of local and European regulations. Providing compliance advice to clinical staff, assisting with the implementation of the Quality Management System. Managing SOP development, review and revision processes as well as SOP distribution, tracking and archiving, training of personnel in the relevant SOPs. Assistance during in-house audits and inspections. Performing internal and external audits phase II-III trials and other applicable audits, follow up on corrective… Show more Ongoing online investigation of local and European regulations. Providing compliance advice to clinical staff, assisting with the implementation of the Quality Management System. Managing SOP development, review and revision processes as well as SOP distribution, tracking and archiving, training of personnel in the relevant SOPs. Assistance during in-house audits and inspections. Performing internal and external audits phase II-III trials and other applicable audits, follow up on corrective actions as deemed necessary. Management of the Scope Intraweb



Premier Research

• United States
• Biotechnology Research
• 700 & Above Employee

• Medical Writer

  • Apr 2004 - Jan 2008

  Medical writing of clinical trial protocol, informed consent form and integrated clinical trial report, development of medical writing SOPs and document templates, quality control of trial documents, training on medical writing SOPs



IMORM GmbH

• Quality Assurance Coordinator

  • Oct 1995 - Mar 2004

  Auditing and quality control of trial documents, conduct of on-site audits, coordination of SOP development. Implementation of QA at IMFORM GmbH, SOP development, preparation of and attendance during inspections and in-house audits



IMFORM GmbH

• CRA/Project Manager

  • Mar 1992 - Sep 1995

  Monitoring of Phase I-III trials, project management of multicentre phase III trial in Germany including all project-related activities: • Submission to regulatory authorities and ethics committees • Organisation of investigator meeting • Reporting trial status to the sponsor • Preparation and maintenance of trial master file • Preparation of case report form • Identification and selection of trial sites • Organisation of trial-related logistics including trial… Show more Monitoring of Phase I-III trials, project management of multicentre phase III trial in Germany including all project-related activities: • Submission to regulatory authorities and ethics committees • Organisation of investigator meeting • Reporting trial status to the sponsor • Preparation and maintenance of trial master file • Preparation of case report form • Identification and selection of trial sites • Organisation of trial-related logistics including trial materials and trial medication • Management of external parties (CRF printing, central laboratory, statistical evaluation) Show less