Wir suchen ab sofort in Görlitz:
Quality Assistent Regulatory Affairs (m/f)

 
     
 

Sysmex Partec is the newly formed collaboration between Partec, a worldwide leading pioneer, developer and manufacturer of flow cytometry systems and Sysmex Corporation, a leading international supplier of in vitro diagnostic products. As part of the multinational group of companies with more than 7.000 employees worldwide. In Görlitz are employed about 170 employees. We are looking to support our team to expand our activities and of course our dynamic company development.

 
 
Responsibilities:  
  • Assist Manager, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing to the project team regulatory information, guidance, training, support and strategic planning based on applicable regulations and guidances issued by the applicable regulatory agencies
  • Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations.
  • Review protocols, consent forms, reports, scientific documents, publications, and related papers, etc., as appropriate for various clinical research projects to ensure compliance with regulations.
  • Ensure the compilation and maintenance of pertinent documentation (e.g., files) required for regulatory compliance for assigned clinical research projects.
  • Serve as a member of groups, teams, or committees related to regulatory affairs, and quality assurance or other designated activities, as appropriate.
  • Perform other related duties as assigned
     
Knowledge, skills
and abilities:
 
  • Working knowledge of and aptitude for activities related to regulatory affairs and quality assurance, both domestic and international.
  • Familiarity with or ability to become familiar with regulatory documents, general contents, organization and the methods of filing and tracking.
  • Familiarity with or ability to become familiar with principles of Good Clinical Practice, Good Laboratory Practice and Good Manufacturing Practice., ISO 13485, 9001, 14971, GMP, GDP, GVP, CAPA, QMS.
  • Experience in preparation of audit plans and checklists against applicable standards, execution of audits, and preparation of comprehensive written audit reports.
  • Good interpersonal skills with the ability to communicate effectively, both orally and in writing, with all levels of staff, and with the public.
  • Ability to be detail oriented with background adequate to deal with scientific issues related to technical regulations and SOPs.
  • Ability to read and synthesize technical material and to prepare clear and concise written documents.
  • Computer literate at a level allowing utilization of event tracking programs, data loading and information processing related to regulatory affairs and quality assurance.
  • Travel as required
  • Fluent English is mandatory
  • German native
     
Requirement:  
  • Requires Bachelor's degree with at least 3 years of related work experience, science degree preferred or equivalent level of education and work experience.
  • Two or more years of work experience in areas relevant to regulatory affairs, quality assurance, and clinical research.
  • Excellent analytical and communication skills, particularly writing skills, are essential.
  • Demonstrated computer literacy is required.
     
Conditions::  
  • 40 hours per week
  • Please name us your salary expectations
  • Place of action Görlitz
 
     
 

Please send your application preferably on:
jobs@sysmex-partec.com

 

or alternative to:
Sysmex Partec GmbH – Human Resources – Am Flugplatz 13 – 02828 Görlitz