Berlin, Berlin, Germany
Experience in the areas of quality (QA & QC) & certification, research & development, production as well as customer order processing and occupational health & safety. A wide range of interdisciplinary experience that enables me to look beyond the `edge of a plate`. Leadership and interpersonal skills in dealing with employees and colleagues, adaptability to new tasks, motivated by new challenges that promote professional and personal development.
• Quality control - Coordination and planning of all quality-relevant analyses for samples and finished products - Preparation of Test Reports and Certificate of Analysis for signing by QA - Stability tests of finished products - Environmental maintenance and equipment monitoring acc. to maintenance plan - Leading to quality systems certification (ISO 9001:2015) and audits - Follow CAPA - Creation of SOP`s for production and quality control close in cooperation with quality management - Qualified to internal auditor - MyMS administrater/coordinator and RAU administrator (temporally) • Responsible to support production - Production logistics - ordering, warehousing and inventory of all incoming material as well as order placement of products at toll manufacturers acc. to specifications; manufacturing of production ampoules and re-packaging of finished goods under regulated conditions • Responsible to support sales and customer handling - Outbound logistics – order acceptance, coordination and preparation of relevant issues for customer order handling under consideration of customs and export matters, Provision of products for shipment, authorized to sign of all relevant transport , export and invoice processes • Member of the HACCP-team • Occupational Health & Safety - Work Safety representative - First aider - Fire protection assistant - Consignor Subclass 6.2 UN 3373 Biological substance, Category B / UN 1845 Dry ice
• Start-up company in 2001 • Establishment of the company structure (equipment qualification, material procurement, etc.) • Development of a company-owned microorganism strain collection of bacteria and yeasts of biosafety level 1 & 2 acc. to German Infection Protection Act • Projectleader of scientific customer projects/commissioned projects (Performing analyses, creation lab protocols, reports and presentations, technical guidance of laboratory staff) • Manufacturing of qualified inoculation material (production ampoules) for the formulation of products • Quality control of incoming materials, pilot products as well as samples and finished products acc. to specification • Creation of SOP`s for production and quality control close in cooperation with quality management • Outbound logistics of samples and finished products acc. to international requirements#Work • • Safety representative, First aider and Fire protection assistant • Consignor Subclass 6.2 UN 3373 Biological substance, Category B / UN 1845 Dry ice
• Development of a flow-through screening rapid assay for the detection of HIV infections (assay development and assay design, diagnostic validation) • Development of lateral flow assays for the differentiation and confirmation of HIV infections • Prototyping of flow-through-device and product packagings • Establishment of in-vitro diagnostics production facility • Production Management • Creation of SOP`s for production and quality control in close cooperation with the quality management • Production- and Outbound Logistics (worldwide)