Documentation specialist

Exothera is a contract development and manufacturing organization (CDMO) dedicated to virus and viral vector production. As a Univercells company, Exothera provides best-in-class bioprocessing expertise that capitalizes on novel manufacturing technologies. The company delivers accelerated process development/optimization to rapidly reach GMP clinical and commercial production of virus and viral vectors. At Exothera and Univercells, our mission is to make health equally accessible to all. 

Apply and be part of this great adventure!  

MISSION

For our different sites in Belgium, we are looking for a dynamic and passionate documentation specialist to support the maintenance department.

RESPONSIBILITIES

  • Creates documentation that meets the regulatory requirements 
  • Working closely with colleagues to ensure that everyone is completing and submitting the necessary documentation
  • Acting as a point of contact for retrieval of specific documentation as required
  • Write, review and update the SOPs relating to documentation collection and storage
  • Keeps up-to-date with the regulatory requirements around documentation and implements changes if necessary
  • Analysis of data submitted via documentation
  • Compilation of reports
  • Deal with long-term storage of information and data protection
  • Participation in internal audits and external regulatory inspections
  • Training of colleagues on the requirements around documentation
  • Revising outdated documents and ensuring that all staff are using the correct version
  • Scan, record, store and archive technical documentation

REQUIREMENTS & QUALIFICATIONS

  • Experience in a technical or maintenance environment 
  • Working knowledge of Quality Assurance systems and cGMPs
  • Organizational skills 
  • IT skills (Microsoft office tools)
  • Written communication skills 
  • Attention to detail 
  • Fluent in French and English 
  • Team working 

Apply and be part of this great adventure!