The Qualified Person In Change (QPIC) oversees all site specific activities with respect to controlled and targeted substances and is responsible for overseeing compliance with the regulations on behalf of the licensed dealers.
The QPIC assumes full responsibility for all transactions involving narcotic, controlled and/or restricted drugs.
Perform daily Controlled Substances activities at site.
Report any proposed security changes, prior to implementation to the Manager to report to Offices of Controlled Substances (OCS).
Maintain records in such a form so that an audit can be conducted at any time by an Inspector.
Ensure that all sales of narcotic, controlled and/or restricted drugs, are made only to those authorized under the regulations to purchase such drugs.
Ensure all advertising material intended for health professionals is in compliance with the Regulations to both Statutes.
Ensure product procurement aligns with regulatory & vault/cage valuation.
Ensure that all drugs are shipped in compliance with the Regulations to the two Statutes.
Ensure that all containers comply with the legislation with respect to tamperproof seals.
Ensure that no advertising or imprint appears on the outside container of narcotics being shipped.
Ensure that prior to release of a narcotic and/or controlled drugs the order is in compliance with the Regulations with respect to signed, verbal and electronic communications.
Ensure that adequate procedures are in effect for the secure storage maintenance of records and actual destruction of unserviceable narcotic and controlled drugs.
Set up and oversee a system for authorizing/recording returns from customers.
Ensure monthly physical inventory of all narcotic and controlled drug materials are performed and maintain appropriate records.
Ensure that adequate procedures are in effect for storage/sampling/movement and shipping of narcotics and controlled drugs
Maintain key control for activities at site.
Maintain site vault/cage and assure compliance with vault/cage valuation.
Perform site waste management process.
Manage, approve and support a monthly report of sales.
Manage and approve year-end inventory of narcotic and controlled substances.
Support the preparation and submission of monthly and annual sales and inventory reporting.
Support keeping the license current and ensure that all products sizes are listed on the licence and appendix and deleted when the product or size is no longer carried by the dealer. The addition of new products or sizes must be approved before manufacture or distribution of the products by the dealer.
Support investigations related to controlled drugs deviations from procedures/processes.
Support GMP audit group, as necessary, in audit of CTS supplies.
Job Requirements :
Graduate with a recognized university degree for which the major requirements were the study of biology, chemistry, biochemistry, pharmacology, pharmacy, microbiology, chemical engineering, medicine, dentistry or veterinary medicine. Courses in pharmacology are required in the absence of a pharmacology/pharmacy degree.
3-5 years relevant working experience in a pharmaceutical environment.
Must not have in the previous 10 years a criminal record in respect of a designated drug offence.
Strong understanding of the relevant acts, regulations, and guidelines and has the ability to apply them to the work-area.
Proven ability to lead and provide direction to all areas of the business, including but not limited to Manufacturing, Packaging, Sales and Marketing, Logistics, Regulatory Affairs, Product Launch, Formulations, Engineering, Security, and all Laboratories.
Excellent written and verbal communication skills.
Excellent ability to follow regulations/guidelines and company SOP’s.
Proven analytical and problem-solving skills.
Knowledge of excel, word, and Microsoft office programs
Ability to manage multiple priorities in a fast-paced and changing environment.
Strong organizational, time management and interpersonal skills.
* This position is located at our Signet site at Weston Road and Steeles* Apotex - 19 months ago