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Life Sciences Stellen Basel
EDP 25 Jahre Jubiläum

Document Specialist, 100% (m/f/d)

Temporärstelle
Einritt:
Stelle: Life Sciences
Art: Temporärstelle

The Document Specialist manages all activities related to archiving and administration of GMP-documents. As a member of the Qualification- & Logistics team, the Document Specialist does also act as a support function for Sample Management.

#DocumentManagement #GMP #Topjob

Our customer, a pharmaceutical company based in the area of Basel, needs reinforcement. For a temporary employment (asap until 31.12.2021) we are looking for a

Document Specialist, 100% (m/f/d)

Major accountabilities:

  • Act as SPOC for all archiving activities within Biologics Analytical Operations
  • Archiving of GMP-Documents
  • Management of external partners related to archiving
  • Maintain high quality and data integrity standards
  • Ensure the archiving database is up-to-date at any time
  • Work according to appropriate standards for quality, ethics, health, safety, environment protection, and information security; actively participate in continuous improvement initiatives
  • Write and review GMP-relevant documents
  • Support the Sample Management team as needed (e.g. Reference sample administration)
  • Act as SME in audits and inspections
  • Represent the department in the relevant network as required
  • Successful and effective execution of assigned tasks within given timelines at expected quality; right first time & right in time; demonstrate initiative and strive for quality
  • Adherence to appropriate standards as defined in Quality Manual, SOPs, ethical, health, safety, environment (HSE), and information security (ISEC) guidelines
  • Refer to annual individual and team objective setting

Background:

  • Bachelor of Science or Apprenticeship with min. 5 years relevant experience in the industry
  • Fluent in English and German (oral and written).
  • Adequate theoretical and scientific knowledge in the relevant area of expertise
  • Practical knowledge and experience in Document management
  • Experience in working in GMP-environment
  • Good communication
  • Basic presentation skills
  • Adequate knowledge of software and computer tools

For questions

… please contact Mr. Renato Imboden by phone on 061 269 90 60

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