Archivist and compliance assistant
Within the Clinical Supply Chain department, GMP and critical study DCS documents are generated in paper format and must be retained for a fairly long period. The person we are looking for will manage the document entries and prepare the archiving boxes. Documents older than 3 years need to be sent to vendors (this preparation is part of the role).
The Responsibilities
- Archivist (paper records)
- Archive GMP and critical study DCS paper records.
- Archiving backlog processing by preparing and transferring CSC critical paper records to an external archiving facility.
- QC oversight of electronical record – Source Clinical
- Perform QC oversight process for new electronical records approved in Source Clinical.
- Sample destruction campaign
- Initiate the destruction requests for the samples destruction campaigns.
- Temperature excursion – As a back-up:
- Manage the temperature excursion for IMP and ensure, in collaboration with the Clinical Supply Planner team, the generation of replacement IMP kits on the relevant systems if needed.
- Open and manage the deviations about temperature excursion for IMP.
Skills and Knowledge Requirements
- Good understanding of GMP-related environments: At least 1 year of experience in the pharmaceutical industry in the field of Quality.
- Deviation Management: The person must know how to create and own deviations.
- Excellent organizational skills.
- Analytical mindset.
- Ability to work in cross-functional teams.
- Structured and meticulous.
- Language Skills: English is mandatory (ability to read and understand English – Please also check the level of English. The person must be able to speak English with the manager during the interview). French is a nice-to-have.
Our Offer
Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way.
Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]
