McKesson Alternate Regulatory Officer in Ontario, Canada

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.

Job Summary

The Alternate Regulatory Officer is responsible for support and back up of the DC Regulatory Officer. The incumbent will support compliance at the DC level to all federal and local regulations and ensures adherence to all company Standard Operating Procedures (SOP) relating to current and applicable regulations. The ARO is responsible to stay current regarding changes to GMP regulations, Health Canada initiatives and other industry policies that could affect our business.

Specific Responsabilities

  1. Assist the RO in ensuring compliance with guidelines and internal policies related to wholesaling and distribution of products

  2. Read, understand and maintain Standard Operating Procedures (SOPs)

a. Provide training to employees on SOPs and GMP related topics

b. Assist with the implementation of Corporate SOPs

  1. Support Distribution Center to ensure they are conducted in accordance to GMP guidelines/regulations and performed in accordance to the established SOPs

  2. Support the self- inspection program. Participate in Health Canada and vendor audits as necessary

  3. Assist with the preparation of audit responses

  4. Preparation of inventory and discrepancy investigation for Narcotics products.

  5. Report regulatory issues and concerns with the potential to impact product quality to management.

  6. Assist with the preparation and completion of Regulatory documentation such as deviations reports, change controls, trending and Route Temperature profiles.

General Responsabilities

  1. Support McKesson’s temperature monitoring system (viewLinc)

  2. Identify compliance risks for narcotics and recommend solutions

  3. When applicable contact manufacturers to obtain assurance of product integrity. Document all communications and results

  4. Support the appropriate use of thermal, validated equipment, ensure deviations are closed in a timeline manner, manage and acknowledge temperature monitoring system according to established processes, investigate and document excursions discovered during protocol execution and regular operations.

  5. Assist the RO in ensuring that the documentation related to the Quality System is accurate, concise and clear including but not limited to Change Controls, Deviations and Customer Complaints

Position Requirements

  • University Degree in Chemistry, Biochemistry, Microbiology or Pharmacology an asset.

  • Experience within a warehouse or distribution environment an asset

  • Strong knowledge of Outlook, Word, Excel and PowerPoint

  • Possess pertinent experience or academia or a combination of both, pertaining to quality control and in product handling in the distribution centre.

  • Proficiency with the Windows operating system

  • Knowledge of Documentum software is an asset

  • Knowledge of the pharmaceutical industry and cold chain

  • Knowledge of Health Canada’s GMP Regulations

  • Knowledge of Narcotic Control Regulations, Precursor Control Regulations, Medical Device Regulations

  • Two years of experience in a similar position

  • Good presentation skills

  • Dynamic and well-organized

  • Proactive and enjoys working as part of a team

  • Works well under pressure

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.

McKesson is an equal opportunity and affirmative action employer – minorities/females/veterans/persons with disabilities.

Qualified applicants will not be disqualified from consideration for employment based upon criminal history.

Agency Statement

No agencies please.

Recruiting Disclaimer

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.

The materials on this site are provided without warranties of any kind, either expressed or implied, including but not limited to warranties regarding the completeness of information contained on this site or in any referenced links. While McKesson Canada attempts to update this site on a timely basis, the information is effective only as of the time and date of posting.

By providing your application to McKesson Canada you hereby consent to McKesson Canada obtaining personal information regarding you that is related to the position applied for. You also consent to McKesson Canada transferring your application details to our recruitment partners for their review and assistance. You also consent to McKesson Canada keeping your application on file.

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.

The information on this site is for information purpose only and is not intended to be relied upon with legal consequence.

Job: Distribution Operations

Organization: McKesson Canada

Title: Alternate Regulatory Officer

Location: Canada-Ontario

Requisition ID: 18004387