Job Description

Description :

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 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. Since this position will be on weekends, he will also be responsible to emit documentation for manufacturing team. In addition, he will have to support the manufacturing on any task that is related to the documentation.

Responsabilities & Duties :

Management of Controlled Products :

• Supervises activities related to controlled substances on site
• Executes and maintains up to date inventory management for controlled substances

• Executes controls and verification of inventory
• Execute investigations in case of discrepancy
• Completes loss/thief report
• Maintains up to date the standard parameters in the used IT tools
• Attends weigh-ins,
• Attends mixtures,
• Makes floor rounds in the factory and in packaging
• Collects and Check Bulks, Blends, Discards, Samples, etc.
• Checks pallets of finished products (QC samples, retentions, stability and rejects)
• Follows up with QA auditors for sample updates in the system
• Performs product checks of raw materials once these products are returned to the vault by QA inspectors.
• Prepares and maintain documentation associated with controlled drugs such as licenses, authorized personnel, permits, reports, with regulatory authorities
• Prepares and document shipments for destruction
• Participates in regulatory audits for controlled drugs

Alcohol Management :

• Performs and maintains inventory management for alcohol

• Carries out checks and verifications of inventories
• Carries out deviation investigations
• Manages the solvent room
• Prepares and maintains documentation associated with alcohol such as licenses, reports, with regulatory authorities
• Reports and corrects any OSH risk in the solvent room
• Participates in regulatory audits for alcohol

Production documentation :

• Know the basics of PMS manufacturing processes
• Print and understand the manufacturing masters
• Check that the information on the production masters matches, notify the responsible group of any anomaly, and ensure that corrections are made
• Make sure to provide the manufacturing files according to the production request
• Prepare and issue Manufacturing files as well as annexes
• Print and verify LIMS labels and sampling plan
• Perform SAP transactions and process the file
• Manage file in corrections
• Make changes to controlled copies
• Emit and verification of logbooks and registers
• Support for internal and external groups related to production
• Always applies and respects good manufacturing practices (GMP)

Continuous Improvement :

• Monitors, comments on and apply changes associated with regulations.
• Participates in improvement projects as an expert on controlled substances

Systems :

• SAP user
• Inventory management user in Excel
• Health Canada Portal (SSCDL)
• Employee access in SuccessFactor(LMS)
• Farel TMS 2.0 consultation

Working conditions & Physical environment

• Office work
• Warehouse, Laboratories and secured installations work
• Manipulation of closed containers and heavy load
• Respect rules of SST, GMP and GLP

Skills, Knowledge & 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)

Education : Certificate
Specialized Graduate Diploma
Diploma of College Studies - Technical
Diploma of College Studies

Experience : 0 years: Or have sufficient knowledge acquired through the combination of eduction, training or work experience to perform their tasks effectively.
0 years: Must have a diploma, a certificate or an attestation issue by a Canadian post-secondary educational institution in a field such as pharmacy, medecine, dentistry, veterinary medecine, pharmacology, chemistry, biology, drug regulation, safety or chain management procurement, pharmacy or laboratory tehcniques etc
0 years: The candidate must meet Health Canada criteria eligibility for an alternate Qualified Person in Charge (aQPIC)
1 years: Minimum one (1) year of experience in the pharmaceutical industry

Pharmascience