McKesson Regulatory Officer Full Time in Newfoundland and Labrador
Branch NL CA
Newfoundland and Labrador
Plan and execute regulatory compliance in the DC, namely by providing expertise and guidance in interpreting governmental regulations, guidelines and internal…
McKesson is in the business of better health and we touch the lives of patients in virtually every aspect of healthcare. At McKesson Canada, we touch the lives of 12 million Canadians every day. We carry more than 35,000 products in 17 distribution centers and ultimately provide distribution to 6,300 retail pharmacies, 1,350 hospitals, long-term care centers, clinics and institutions all over Canada. But we’re so much more than a distribution company. We’ve automated 2,500 retail pharmacies and dispense over 100 million doses a year through our automation solutions. Manufacturers, healthcare providers and patients count on us for a full range of services that contribute to the quality and safety of care for us all.
At McKesson Canada, you’ll help us carry out our mission to improve lives and advance healthcare. Working here is your opportunity to shape an industry that’s vital to us all.
The Regulatory Officer is responsible for ensuring compliance at the DC level to all federal and local regulations. The incumbent ensures and monitors adherence to all company SOPs relating to current GMPs and other applicable regulations. The incumbent stays current with ongoing changes in GMP regulations, Health Canada initiatives and other industry policies that could affect the McKesson Canada Drug Wholesale and McKesson Distribution Partners (where applicable) businesses.
This position has direct reporting line to the Manager, Quality and Compliance
This position may have directly supervise ARO position in DCs where ARO position exist
Duties and responsibilities include but are not limited to:
Plan and execute regulatory compliance in the DC, namely by providing expertise and guidance in interpreting governmental regulations, guidelines and internal policies, related to wholesaling and distribution of products.
Responsible to ensure compliance of the Quality System, including but not limited to Change Controls, Deviations, Recalls, Returns and Customer Complaints. Ensures and enforces Good Documentation Practices on all applicable documents relating to GMPs.
Communicate and summarize compliance performance and results of the DC to the DCM and Quality & Compliance Manager, e.g. highlight self-inspection issues to the DCM or DC board regularly.
Responsible for training of DC management, warehouse employees, customer service, and returns personnel (where applicable) on SOPs and GMP related topics. Responsibilities include the planning, execution and maintenance of employee training records as well as testing to ensure training effectiveness.
Manage the local DC GMP self-inspection program. Initiate and follow up on corrective actions to be taken in areas identified as non-compliant and develop preventive actions in conjunction with the Distribution Center Manager.
Active participation in Health Canada and vendor audits. Prepare audit responses in a timely manner. Ensure observations are addressed and closed within reasonable timeframe and followed up if not received within that timeframe.
Actively participate in writing, review of SOPs. Maintain documents current and available for employees in a controlled manner and responsible for the proper and adequate implementation of SOPs .
Ensure receiving, storage, picking, packing (temperature, stock rotation, sanitation, cold chain, freight inbound and outbound) are conducted in accordance to GMP guidelines and regulations and performed in accordance with the current SOPs.
Ensure McKesson’s temperature monitoring system is functional at all times and that the Temperature Profiling system, both the DC Temperature Monitoring System and the Temperature Logger Systems, are utilized according to SOPs.
When applicable, contact manufacturers to obtain guidance on product integrity when a deviation occurs due to temperature or any instance where the quality and safety of the products may be comprised. Ensures that all communications, results and final outcome are documented appropriately.
Ensure thermal equipment containing drug products are qualified or validated and any CAPA’s are closed based on the results of the qualification / validation. Ensure accurate and timely warehouse temperature mapping is performed. Review and approve protocols.
Assist with the preparation, inventory and discrepancy investigation for Narcotics products.
Report regulatory issues and concerns with the potential to impact product quality to management.
Support Site Security Officer in managing narcotic cage/vault security and access
Assist in the investigation and report all suspicious narcotic transactions and losses
Assist with the authorization, processing and managing all returned narcotic product
Supervise the ARO work, do the performance evaluation and prepare development plan when applicable.
Bachelor of Science degree with a major in one of the following: chemistry, biochemistry, pharmacology, pharmacy, microbiology, chemical engineering, medicine, dentistry or veterinary medicine.
5 years of experience in a similar position.
Experience pertaining to quality assurance and control relating to a distributor and wholesaler environment is a strong asset
Knowledge of Narcotic Control Regulations, Precursor Control Regulations, Medical Device Regulations, is an asset.
Benefits & Company Statement
McKesson believes superior performance – individual and team – that helps us drive innovations and solutions to promote better health should be recognized and rewarded. We provide a competitive compensation program to attract, retain and motivate a high-performance workforce, and it’s flexible enough to meet the different needs of our diverse employee population.
We are in the business of better health and we touch the lives of patients in virtually every aspect of healthcare. We partner with payers, hospitals, physician offices, pharmacies, pharmaceutical companies and others across the spectrum of care to build healthier organizations that deliver better care to patients in every setting.
But we can’t do it without you. Every single McKesson employee contributes to our mission—whatever your title, whatever your role, you act as a catalyst in a chain of events that helps millions of people all over the globe. Talented, compassionate people are the future of our company—and of healthcare. At McKesson, you’ll collaborate on the products and solutions that help us carry out our mission to improve lives and advance healthcare. Working here is your opportunity to shape an industry that’s vital to us all.
Qualified applicants will not be disqualified from consideration for employment based upon criminal history.
Job Family Title: CAN-QPIC 1
The material contained herein is provided for informational purpose only. All open jobs offered by McKesson Canada on this recruitment system are subject to specific job skill requirements. The job skill requirements, qualifications, and preferred experience are determined by a subsidiary, office or department within the company which is offering the position, and all positions are subject to local prevailing employment laws and restrictions. This would include immigration laws pertaining to work authorization requirements and any other applicable government permissions or compliance.
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McKesson Canada is an equal opportunity employer and values diversity in its workforce. We encourage applications from all qualified individuals and will accommodate applicants’ needs, up to the point of undue hardship, throughout all stages of the recruitment and selection process.
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Primary Location: Canada-Newfoundland (NL)
Job: Distribution Operations
Organization: McKesson Canada
Job Type: Full-time
Job Posting: Jul 27, 2018