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Document Specialist

Harvey Nash IT Recruitment Switzerland

Posted on Feb 9, 2021 by Harvey Nash IT Recruitment Switzerland

Basel, Switzerland
Immediate Start
Annual Salary

For our client in Basel we are searching for Document Specialist for 10 months project

Job Title: Document Specialist

Duration: 01/03/2021 to 31/12/2021

Location: Basel

Workload: 100%

Department: GDD TRD Biologics

Job Purpose:
The Document Specialist manages all activities related to archiving and administration of GMP-documents. This includes, but is not limited to, archiving of documents, management of relevant external partners related to archiving, and general support with regard to document management. As a member of the Qualification- & Logistics team, the Document Specialist does also act as a support function for Sample Management.

Major Accountabilities and activities:
1. Act as SPOC for all archiving activities within Biologics Analytical Operations
2. Archiving of GMP-Documents
3. Management of external partners related to archiving
4. Maintain high quality and data integrity standards
5. Ensure the archiving database is up-to-date at any time
6. Work according to appropriate standards for quality, ethics, health, safety, environment protection, and information security; actively participate in continuous improvement initiatives
7. Write and review GMP-relevant documents
8. Support the Sample Management team as needed (eg Reference sample administration)
9. Act as SME in audits and inspections
10. Represent the department in the relevant network as required

Key Performance Indicators:
1. 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
2. Adherence to appropriate standards as defined in Quality Manual, SOPs, ethical, health, safety, environment (HSE), and information security (ISEC) guidelines
3. Refer to annual individual and team objective setting

Ideal Background:
Education: Bachelor of Science or Apprenticeship with min. 5 years relevant experience in the industry
Languages: Fluent in English (oral and written).

Adequate skills in local site-language (German), as required for the position

Experience/Professional requirement:
- 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

Reference: 1089346914

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