Doc Manager GMP
On behalf of one of the top Pharma companies who are looking for a Document Specialist, on a contract basis for at least 10 months to be based in Basel. This is a chance to be a part of one of the largest pharmaceutical companies in the world, where extensions are expected allowing you to gain exposure with a reputable name and ultimately build further value for your profile. This is a contract with guaranteed working hours of 40 hours per week.
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 (e.g. 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
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
- 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
Call me Daniel Watson at NonStop Recruitment now for a confidential conversation. Contact me on D.Watson@nonstopconsulting.com or +41 435 080 817, please send your CV in word format OR if this does not sound like the opportunity for you, but you are a Contract professional within the pharmaceutical, medical device or biotech industry, please feel free to get in touch, to see other opportunities we may have within this field.
NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.
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