Spécialiste substances contrôlées

4 months ago


Candiac, Canada Pharmascience Full time

The coordinator is responsible for managing and supervising activities related to controlled drugs, alcohol and cannabis in accordance with the laws and regulations in force. He is responsible for maintaining, updating and monitoring the management processes in place (inventories, FAT, security, etc.). He is responsible for access to the contents of vaults, cages and alcohol room on the site, inter-site transfers, FAT (transfer authorizations), control of controlled drugs, alcohol and cannabis in production and / or laboratory as well as transfers for destruction. He is responsible for monitoring Import / Export permits and for producing the various reports required by regulations. He participates in audits carried out by regulatory agencies affecting controlled substances.

Responsibilities:

MANAGEMENT OF CONTROLLED PRODUCTS

Supervise activities related to controlled substances on site. Execute and maintain up to date inventory management for controlled substances Execute periodic inventory on a regular basis Execute controls and verification of inventory Execute investigations in case of discrepancy Complete loss/thief report Maintain up to date the standard parameters in the used IT tools Prepare and maintain documentation associated with controlled drugs such as licenses, authorized personnel, permits, reports, with regulatory authorities Prepare and perform follow-ups for import / export permits Authorize and coordinate the shipping / receiving of products in accordance with the authorized capacities. Prepare and document shipments for destruction Document controls and updates for approved installations Participate in regulatory audits for controlled drugs

Alcohol management

Perform and maintain inventory management for alcohol Carry out checks and verifications of inventories Carry out deviation investigations Manage the solvent room Prepare and maintain documentation associated with alcohol such as licenses, reports, with regulatory authorities Prepare and document shipments for destruction of hazardous materials Report and correct any OSH risk in the solvent room Participate in regulatory audits for alcohol

CONTINUOUS IMPROVEMENT AND OTHERS

Monitor, comment on and apply changes associated with regulations. Optimize / Revise processes and tools (SOPs, WIs, tools, guides, etc.) to improve efficiency and eliminate non-added values Participate in improvement projects as an expert on controlled substances

SYSTEMS

SAP user LIMS user Inventory management and investigation report tools user in Excel Health Canada Portal (SSCDL) Adobe user Opentext Contributor(DMS) Employee access in SuccessFactor(LMS) Farel TMS 2.0 consultation

Skills, Knowledge and Abilities:

SAP and Excel systems knowledge Knowledge of current laws and regulations (Narcotics, GMP,GLP, SST) Hability to effectively manage time and multiple priorities Rigor, analytical spirit, sens of observation, logic Ability to solve problems Action Oriented Bilingual english/french (oral and written)