archivist and compliance assistant.

As part of the Clinical Supply Compliance team, the Archivist and Compliance Assistant will :

• Ensure the archive of Clinical Supply Chain (CSC) critical paper records.
• Perform the quality check (QC) oversight of electronical records in Source Clinical.
• Assist the Clinical Supply Compliance Process & Governance Lead in the sample destruction compaigns.
• Assess the temperature excursion for IMP as a back-up.

General Role:

• Archivist (paper records)• Archive GMP and critical study DCS paper records.• Archiving backlog processing by preparing and transferring CSC critical paper records to anexternal 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 SupplyPlanner team, the generation of replacement IMP kits on the relevant systems if needed.• Open and manage the deviations about temperature excursion for IMP.

As an Archivist and compliance Assistant :

• Good understanding in GMP related environment: at least 1 year of experience in the pharmaceutical industry in the field of Quality.
• Excellent organizational skill
• Analytical mindset
• Ability to work on cross functional teams.
• Excellent Team spirit
• Fluency in English and French is mandatory.
• IT: experience working with Veeva (Source Clinical) is an advantage.