Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • Toronto

Description

Description
 
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

 
As a Documentation Management Specialist, you will be responsible for the development, revision, and distribution of active master documents such as Policies, Quality Standards, Standard Operating Procedures, Guidance Documents and Work Instructions.
The Document Management Specialist will be required to work within the QMS to facilitate alignment across multiple documents and may manage multiple assignments simultaneously that support all business activities for McKesson while ensuring compliance to client requirements, proper workflows and appropriate reviews and approvals.
In this position, the incumbent is required to develop and manage an efficient document architecture that is compliant to company Global, Regulatory, Privacy, Ethics and Compliance requirements, as well as for the retention program (archive and destruction of records) that support all business activities.
 
Specific Responsibilities
 
Specific duties generally include but are not limited to the following:
 
 
Develop and manage a central records management process designed through the lifecycle of document management.
Control the process for authoring, review, approval and subsequent distribution, archiving and destruction of Master GxP Documents (SOPs, GD’s, WI’s, Master Records, Reports and other GxP documents).
Develop and maintain site policies/procedures.
Describe and govern the system to ensure GxP documentation and records are managed in accordance with Global Quality requirements, regulations and GMPs.
Function as the Subject Matter Expert (SME) on applicable Regulations.
Provide technical and regulatory guidance with regard to regulations to internal and external stake-holders to ensure overall quality and compliance.
Create and provide appropriate metrics to identify status of documents (i.e., tracking for status, documents approaching expiration, volume of reviews, review time etc).
Ensure offsite records storage is aligned and managed within the policies and procedures of the document management system and are integrated with the life cycle approach to the GxP-related documents.
Provide subject matter expertise during internal audits and external inspections and audits.
Ensure deployment and implementation process sustainability and effectiveness.
Keep current of updates to applicable Regulations.
Review applicable Change Control Documents to ensure referenced changes are made and are compliant.
 
 
 
Qualifications
 
Requirements
Post-secondary education (University degree preferred) in business, operations management, science, engineering or related areas preferred;
Four to six years’ experience and understanding of quality in the pharmaceutical/health care industry
Thorough knowledge of cGMPs, regulatory, privacy and compliance requirements are required.
Ability to work independently and work well with others and must spend a significant amount of time working with the operations team to understand processes.
Advanced knowledge of risk and compliance methodologies and processes.  This involves strategizing, planning, managing, writing, and/or reviewing the activities and documents.
Knowledge and competencies in document management software applications and solutions, including experience or training in document management system.  
Strong customer focus and ability to prioritize and adapt to business needs.
Ability to communicate and work with a very broad spectrum of professional and technical staff to effectively manage documents and records in an efficient and practical

About the company

McKesson Corporation, currently ranked 5th on the FORTUNE 500, is a healthcare services and information technology company dedicated to making the business of healthcare run better.

For businesses across healthcare, being healthy means having what you need to operate more efficiently and improve the lives of patients. McKesson champions those working on the front lines of healthcare by helping them deliver better care at lower costs. We see the industry the way no one else can: comprehensively. And we’re confident in the impact we create because of that view.

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