For our customer located in Basel/Switzerland we are currently looking for a: Document Specialist (m/f/d)
Department: GDD TRD Biologics
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.
Tasks & Responsibilities
Major Accountabilities and activities
- 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
Key Performance Indicators
- 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
- Education:Bachelor of Science or
- 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
- 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
Did we catch your interest?
The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).
Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.